Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza. (NCT NCT06178991)
NCT ID: NCT06178991
Last Updated: 2025-12-04
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
PHASE3
Target enrollment
8795 participants
Primary outcome timeframe
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Results posted on
2025-12-04
Participant Flow
Participant milestones
| Measure |
Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B)
Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination B), intramuscularly on Day 1.
|
Cohort 3, Arm F: COVID-19 Vaccine
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm G: Licensed Influenza Vaccine
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm H: Investigational Influenza Vaccine
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
|
Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo
Participants 18 to 64 years of age were administered with Influenza vaccine and coronavirus disease 2019 (COVID-19) vaccine (combination A) and placebo, intramuscularly on Day 1.
|
Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration
Participants 18 to 64 years of age were administered concomitantly with COVID-19 vaccine and licensed influenza vaccine administered, intramuscularly on Day 1.
|
Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo
Participants 18 to 64 years of age were administered with Influenza and COVID-19 vaccine (combination B) and placebo, intramuscularly on Day 1.
|
Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration
Participants 18 to 64 years of age were administered concomitantly with COVID-19 vaccine and licensed influenza vaccine administered, intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
COMPLETED
|
1110
|
1125
|
571
|
583
|
304
|
148
|
2938
|
1468
|
|
Overall Study
STARTED
|
1197
|
1195
|
607
|
609
|
313
|
160
|
3142
|
1572
|
|
Overall Study
Vaccinated
|
1189
|
1191
|
605
|
607
|
309
|
159
|
3127
|
1563
|
|
Overall Study
NOT COMPLETED
|
87
|
70
|
36
|
26
|
9
|
12
|
204
|
104
|
Reasons for withdrawal
| Measure |
Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B)
Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination B), intramuscularly on Day 1.
|
Cohort 3, Arm F: COVID-19 Vaccine
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm G: Licensed Influenza Vaccine
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm H: Investigational Influenza Vaccine
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
|
Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo
Participants 18 to 64 years of age were administered with Influenza vaccine and coronavirus disease 2019 (COVID-19) vaccine (combination A) and placebo, intramuscularly on Day 1.
|
Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration
Participants 18 to 64 years of age were administered concomitantly with COVID-19 vaccine and licensed influenza vaccine administered, intramuscularly on Day 1.
|
Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo
Participants 18 to 64 years of age were administered with Influenza and COVID-19 vaccine (combination B) and placebo, intramuscularly on Day 1.
|
Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration
Participants 18 to 64 years of age were administered concomitantly with COVID-19 vaccine and licensed influenza vaccine administered, intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
7
|
7
|
5
|
2
|
6
|
44
|
23
|
|
Overall Study
Lost to Follow-up
|
68
|
57
|
25
|
18
|
2
|
4
|
133
|
65
|
|
Overall Study
Death
|
1
|
0
|
1
|
1
|
1
|
0
|
2
|
1
|
|
Overall Study
Randomized but not Vaccinated
|
8
|
4
|
2
|
2
|
4
|
1
|
15
|
9
|
|
Overall Study
Other: Unspecified
|
1
|
1
|
1
|
0
|
0
|
1
|
7
|
6
|
|
Overall Study
Physician Decision
|
2
|
1
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.
Baseline characteristics by cohort
| Measure |
Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo
n=309 Participants
Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination A) and placebo, intramuscularly on Day 1.
|
Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration
n=159 Participants
Participants 18 to 64 years of age were administered concomitantly with COVID-19 vaccine and licensed influenza vaccine administered, intramuscularly on Day 1.
|
Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo
n=3127 Participants
Participants 18 to 64 years of age were administered with Influenza and COVID-19 vaccine (combination B) and placebo, intramuscularly on Day 1.
|
Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration
n=1563 Participants
Participants 18 to 64 years of age were administered concomitantly with COVID-19 vaccine and licensed influenza vaccine administered, intramuscularly on Day 1.
|
Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B)
n=1189 Participants
Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination B), intramuscularly on Day 1.
|
Cohort 3, Arm F: COVID-19 Vaccine
n=1191 Participants
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm G: Licensed Influenza Vaccine
n=605 Participants
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm H: Investigational Influenza Vaccine
n=607 Participants
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
|
Total
n=8750 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
44.2 Years
STANDARD_DEVIATION 12.13 • n=3 Participants
|
44.7 Years
STANDARD_DEVIATION 13.89 • n=3 Participants
|
44.0 Years
STANDARD_DEVIATION 12.91 • n=6 Participants
|
44.2 Years
STANDARD_DEVIATION 12.53 • n=3 Participants
|
44.3 Years
STANDARD_DEVIATION 12.72 • n=15 Participants
|
45.3 Years
STANDARD_DEVIATION 12.45 • n=1 Participants
|
44.5 Years
STANDARD_DEVIATION 12.69 • n=15 Participants
|
45.1 Years
STANDARD_DEVIATION 12.82 • n=407 Participants
|
44.4 Years
STANDARD_DEVIATION 12.73 • n=202 Participants
|
|
Sex: Female, Male
Female
|
180 Participants
n=3 Participants
|
95 Participants
n=3 Participants
|
1740 Participants
n=6 Participants
|
848 Participants
n=3 Participants
|
654 Participants
n=15 Participants
|
683 Participants
n=1 Participants
|
336 Participants
n=15 Participants
|
332 Participants
n=407 Participants
|
4868 Participants
n=202 Participants
|
|
Sex: Female, Male
Male
|
129 Participants
n=3 Participants
|
64 Participants
n=3 Participants
|
1387 Participants
n=6 Participants
|
715 Participants
n=3 Participants
|
535 Participants
n=15 Participants
|
508 Participants
n=1 Participants
|
269 Participants
n=15 Participants
|
275 Participants
n=407 Participants
|
3882 Participants
n=202 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
105 Participants
n=3 Participants
|
51 Participants
n=3 Participants
|
966 Participants
n=6 Participants
|
491 Participants
n=3 Participants
|
457 Participants
n=15 Participants
|
435 Participants
n=1 Participants
|
224 Participants
n=15 Participants
|
225 Participants
n=407 Participants
|
2954 Participants
n=202 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
201 Participants
n=3 Participants
|
108 Participants
n=3 Participants
|
2145 Participants
n=6 Participants
|
1055 Participants
n=3 Participants
|
719 Participants
n=15 Participants
|
739 Participants
n=1 Participants
|
372 Participants
n=15 Participants
|
371 Participants
n=407 Participants
|
5710 Participants
n=202 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
16 Participants
n=6 Participants
|
17 Participants
n=3 Participants
|
13 Participants
n=15 Participants
|
17 Participants
n=1 Participants
|
9 Participants
n=15 Participants
|
11 Participants
n=407 Participants
|
86 Participants
n=202 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
22 Participants
n=6 Participants
|
17 Participants
n=3 Participants
|
13 Participants
n=15 Participants
|
4 Participants
n=1 Participants
|
4 Participants
n=15 Participants
|
2 Participants
n=407 Participants
|
63 Participants
n=202 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=3 Participants
|
6 Participants
n=3 Participants
|
111 Participants
n=6 Participants
|
58 Participants
n=3 Participants
|
35 Participants
n=15 Participants
|
34 Participants
n=1 Participants
|
18 Participants
n=15 Participants
|
20 Participants
n=407 Participants
|
286 Participants
n=202 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
12 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
9 Participants
n=15 Participants
|
3 Participants
n=1 Participants
|
2 Participants
n=15 Participants
|
2 Participants
n=407 Participants
|
31 Participants
n=202 Participants
|
|
Race (NIH/OMB)
Black or African American
|
74 Participants
n=3 Participants
|
37 Participants
n=3 Participants
|
812 Participants
n=6 Participants
|
392 Participants
n=3 Participants
|
277 Participants
n=15 Participants
|
295 Participants
n=1 Participants
|
143 Participants
n=15 Participants
|
157 Participants
n=407 Participants
|
2187 Participants
n=202 Participants
|
|
Race (NIH/OMB)
White
|
227 Participants
n=3 Participants
|
111 Participants
n=3 Participants
|
2106 Participants
n=6 Participants
|
1051 Participants
n=3 Participants
|
830 Participants
n=15 Participants
|
842 Participants
n=1 Participants
|
425 Participants
n=15 Participants
|
419 Participants
n=407 Participants
|
6011 Participants
n=202 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
32 Participants
n=6 Participants
|
24 Participants
n=3 Participants
|
15 Participants
n=15 Participants
|
7 Participants
n=1 Participants
|
7 Participants
n=15 Participants
|
2 Participants
n=407 Participants
|
90 Participants
n=202 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
32 Participants
n=6 Participants
|
19 Participants
n=3 Participants
|
10 Participants
n=15 Participants
|
6 Participants
n=1 Participants
|
6 Participants
n=15 Participants
|
5 Participants
n=407 Participants
|
82 Participants
n=202 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 at least 1 dose of the study intervention. Participants were grouped according to the vaccine as administered in the analysis based on the safety population. Here "Overall Number of Participants Analyzed" signifies number of participants reporting at least 1 response in the e-diary or CRF after vaccination. As planned this outcome measure evaluated local reactions in investigational vaccine extremity.
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 3, Arm F: COVID-19 Vaccine
n=159 Participants
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm G: Licensed Influenza Vaccine
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm H: Investigational Influenza Vaccine
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
|
Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo
n=308 Participants
Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination A) and placebo, intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Cohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity
|
59.1 Percentage of participants
Interval 51.1 to 66.8
|
—
|
—
|
74.7 Percentage of participants
Interval 69.4 to 79.4
|
PRIMARY outcome
Timeframe: From Day 1 through Day 7 after Vaccination [Vaccination on Day1]Population: Safety analysis population included all participants who received at least 1 dose of the study intervention. Participants were grouped according to the vaccine as administered in the analysis based on the safety population. Here "Overall Number of Participants Analyzed" signifies number of participants reporting at least 1 response in the e-diary or CRF after vaccination. As planned this outcome measure evaluated local reactions in investigational vaccine extremity.
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 3, Arm F: COVID-19 Vaccine
n=1560 Participants
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm G: Licensed Influenza Vaccine
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm H: Investigational Influenza Vaccine
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
|
Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo
n=3111 Participants
Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination A) and placebo, intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Cohort 2: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity
|
63.5 Percentage of participants
Interval 61.0 to 65.9
|
—
|
—
|
73.4 Percentage of participants
Interval 71.8 to 75.0
|
PRIMARY outcome
Timeframe: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]Population: Safety analysis population included all participants who received at least 1 dose of the study intervention. Participants were grouped according to the vaccine as administered in the analysis based on the safety population. Here "Overall Number of Participants Analyzed" signifies number of participants reporting at least 1 response in the e-diary or CRF after vaccination. As planned this outcome measure evaluated local reactions in investigational vaccine extremity.
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 3, Arm F: COVID-19 Vaccine
n=1188 Participants
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm G: Licensed Influenza Vaccine
n=604 Participants
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm H: Investigational Influenza Vaccine
n=606 Participants
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
|
Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo
n=1186 Participants
Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination A) and placebo, intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Cohort 3: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity
|
62.5 Percentage of participants
Interval 59.6 to 65.2
|
34.8 Percentage of participants
Interval 31.0 to 38.7
|
66.3 Percentage of participants
Interval 62.4 to 70.1
|
73.4 Percentage of participants
Interval 70.8 to 75.9
|
PRIMARY outcome
Timeframe: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]Population: Safety analysis population included all participants who received at least 1 dose of the study intervention. Participants were grouped according to the vaccine as administered in the analysis based on the safety population. 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 including fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain were recorded in an 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 3, Arm F: COVID-19 Vaccine
n=159 Participants
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm G: Licensed Influenza Vaccine
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm H: Investigational Influenza Vaccine
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
|
Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo
n=308 Participants
Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination A) and placebo, intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Cohort 1: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
|
54.1 Percentage of participants
Interval 46.0 to 62.0
|
—
|
—
|
71.8 Percentage of participants
Interval 66.4 to 76.7
|
PRIMARY outcome
Timeframe: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]Population: Safety analysis population included all participants who received at least 1 dose of the study intervention. Participants were grouped according to the vaccine as administered in the analysis based on the safety population. 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 including fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain were recorded in an 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 3, Arm F: COVID-19 Vaccine
n=1560 Participants
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm G: Licensed Influenza Vaccine
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm H: Investigational Influenza Vaccine
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
|
Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo
n=3111 Participants
Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination A) and placebo, intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Cohort 2: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
|
59.9 Percentage of participants
Interval 57.4 to 62.3
|
—
|
—
|
70.8 Percentage of participants
Interval 69.2 to 72.4
|
PRIMARY outcome
Timeframe: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]Population: Safety analysis population included all participants who received at least 1 dose of the study intervention. Participants were grouped according to the vaccine as administered in the analysis based on the safety population. 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 including fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain were recorded in an 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 3, Arm F: COVID-19 Vaccine
n=1188 Participants
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm G: Licensed Influenza Vaccine
n=604 Participants
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm H: Investigational Influenza Vaccine
n=606 Participants
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
|
Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo
n=1186 Participants
Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination A) and placebo, intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Cohort 3: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
|
52.1 Percentage of participants
Interval 49.2 to 55.0
|
43.9 Percentage of participants
Interval 39.9 to 47.9
|
61.1 Percentage of participants
Interval 57.0 to 65.0
|
66.7 Percentage of participants
Interval 63.9 to 69.4
|
PRIMARY outcome
Timeframe: From Vaccination on Day 1 through 4 Weeks after VaccinationPopulation: Safety analysis population included all participants who received at least 1 dose of the study intervention. Participants were grouped according to the vaccine as administered in the analysis based on the safety population.
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 3, Arm F: COVID-19 Vaccine
n=159 Participants
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm G: Licensed Influenza Vaccine
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm H: Investigational Influenza Vaccine
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
|
Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo
n=309 Participants
Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination A) and placebo, intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Cohort 1: Percentage of Participants Reporting Adverse Events (AEs) From Vaccination Through 4 Weeks After Vaccination
|
10.1 Percentage of participants
Interval 5.9 to 15.8
|
—
|
—
|
5.8 Percentage of participants
Interval 3.5 to 9.1
|
PRIMARY outcome
Timeframe: From Vaccination on Day 1 through 4 Weeks after VaccinationPopulation: Safety analysis population included all participants who received at least 1 dose of the study intervention. Participants were grouped according to the vaccine as administered in the analysis based on the safety population.
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 3, Arm F: COVID-19 Vaccine
n=1563 Participants
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm G: Licensed Influenza Vaccine
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm H: Investigational Influenza Vaccine
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
|
Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo
n=3127 Participants
Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination A) and placebo, intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Cohort 2: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination
|
6.1 Percentage of participants
Interval 4.9 to 7.4
|
—
|
—
|
6.4 Percentage of participants
Interval 5.6 to 7.3
|
PRIMARY outcome
Timeframe: From Vaccination on Day 1 through 4 Weeks after VaccinationPopulation: Safety analysis population included all participants who received at least 1 dose of the study intervention. Participants were grouped according to the vaccine as administered in the analysis based on the safety population.
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 3, Arm F: COVID-19 Vaccine
n=1191 Participants
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm G: Licensed Influenza Vaccine
n=605 Participants
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm H: Investigational Influenza Vaccine
n=607 Participants
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
|
Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo
n=1189 Participants
Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination A) and placebo, intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Cohort 3: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination
|
4.8 Percentage of participants
Interval 3.6 to 6.2
|
4.1 Percentage of participants
Interval 2.7 to 6.0
|
4.1 Percentage of participants
Interval 2.7 to 6.0
|
3.8 Percentage of participants
Interval 2.8 to 5.0
|
PRIMARY outcome
Timeframe: From Vaccination on Day 1 through 6 Months after VaccinationPopulation: Safety analysis population included all participants who received at least 1 dose of the study intervention. Participants were grouped according to the vaccine as administered in the analysis based on the safety population.
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.
Outcome measures
| Measure |
Cohort 3, Arm F: COVID-19 Vaccine
n=159 Participants
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm G: Licensed Influenza Vaccine
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm H: Investigational Influenza Vaccine
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
|
Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo
n=309 Participants
Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination A) and placebo, intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Cohort 1: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
|
2.5 Percentage of participants
Interval 0.7 to 6.3
|
—
|
—
|
0.6 Percentage of participants
Interval 0.1 to 2.3
|
PRIMARY outcome
Timeframe: From Vaccination on Day 1 through 6 Months after VaccinationPopulation: Safety analysis population included all participants who received at least 1 dose of the study intervention. Participants were grouped according to the vaccine as administered in the analysis based on the safety population.
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.
Outcome measures
| Measure |
Cohort 3, Arm F: COVID-19 Vaccine
n=1563 Participants
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm G: Licensed Influenza Vaccine
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm H: Investigational Influenza Vaccine
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
|
Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo
n=3127 Participants
Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination A) and placebo, intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Cohort 2: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
|
1.4 Percentage of participants
Interval 0.9 to 2.1
|
—
|
—
|
0.7 Percentage of participants
Interval 0.5 to 1.1
|
PRIMARY outcome
Timeframe: From Vaccination on Day 1 through 6 Months after VaccinationPopulation: Safety analysis population included all participants who received at least 1 dose of the study intervention. Participants were grouped according to the vaccine as administered in the analysis based on the safety population.
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.
Outcome measures
| Measure |
Cohort 3, Arm F: COVID-19 Vaccine
n=1191 Participants
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm G: Licensed Influenza Vaccine
n=605 Participants
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm H: Investigational Influenza Vaccine
n=607 Participants
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
|
Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo
n=1189 Participants
Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination A) and placebo, intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Cohort 3: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
|
1.3 Percentage of participants
Interval 0.7 to 2.1
|
0.8 Percentage of participants
Interval 0.3 to 1.9
|
1.2 Percentage of participants
Interval 0.5 to 2.4
|
0.8 Percentage of participants
Interval 0.4 to 1.5
|
PRIMARY outcome
Timeframe: At 4 Weeks after VaccinationPopulation: Evaluable immunogenicity population (EIP): eligible participants, received study intervention per randomization, had minimum 1 valid and determinate immunogenicity result from blood sample collected within 27- 42 days postvaccination, and had no major protocol violations. EIP for HAI of Cohort 2 was utilized. "Number Analyzed": participants evaluable for specific strains. All participants for "Overall Number of Participants Analyzed" added to the data but may not be present as "Number Analyzed".
GMTs and the corresponding 2-sided confidence interval (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantitation (LLOQ) were set to 0.5 \*LLOQ. GMTs were reported in the descriptive data section of this outcome measure. GMRs were reported in the statistical analysis section. Data was reported for the following strains: H1N1, H3N2 and Victoria.
Outcome measures
| Measure |
Cohort 3, Arm F: COVID-19 Vaccine
n=967 Participants
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm G: Licensed Influenza Vaccine
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm H: Investigational Influenza Vaccine
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
|
Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo
n=1923 Participants
Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination A) and placebo, intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Cohort 2: Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination: Non-inferiority
H1N1
|
136.3 Titer
Interval 125.9 to 147.5
|
—
|
—
|
188.3 Titer
Interval 178.2 to 198.9
|
|
Cohort 2: Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination: Non-inferiority
H3N2
|
96.9 Titer
Interval 90.6 to 103.5
|
—
|
—
|
165.9 Titer
Interval 158.0 to 174.1
|
|
Cohort 2: Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination: Non-inferiority
Victoria
|
56.4 Titer
Interval 52.4 to 60.6
|
—
|
—
|
37.4 Titer
Interval 35.5 to 39.5
|
PRIMARY outcome
Timeframe: At 4 Weeks after VaccinationPopulation: EIP: eligible participants, received study intervention per randomization, had minimum 1 valid and determinate immunogenicity result from blood sample collected within 27- 42 days postvaccination, and had no major protocol violations. EIP for HAI of Cohort 2 was utilized. "Number Analyzed": participants evaluable for specific strains. All participants for "Overall Number of Participants Analyzed" added to the data but may not be present as "Number Analyzed".
Seroconversion was defined as having an HAI titer \<1:10 prior to vaccination and greater than or equal to (\>=) 1:40 at the postvaccination time point of interest, or an HAI titer of \>=1:10 prior to vaccination with a minimum 4-fold rise at the postvaccination time point of interest. Percentage of participants with seroconversion were reported in the descriptive data section of this outcome measure. Difference in percentage of participants with seroconversion were reported in the statistical analysis section. Data was reported for the following strains: H1N1, H3N2 and Victoria.
Outcome measures
| Measure |
Cohort 3, Arm F: COVID-19 Vaccine
n=967 Participants
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm G: Licensed Influenza Vaccine
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm H: Investigational Influenza Vaccine
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
|
Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo
n=1923 Participants
Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination A) and placebo, intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Cohort 2: Percentage of Participants and Difference in Percentage of Participants With Strain-Specific HAI Seroconversion at 4 Weeks After Vaccination: Non-inferiority
H1N1
|
54.9 Percentage of participants
Interval 51.7 to 58.1
|
—
|
—
|
72.8 Percentage of participants
Interval 70.7 to 74.8
|
|
Cohort 2: Percentage of Participants and Difference in Percentage of Participants With Strain-Specific HAI Seroconversion at 4 Weeks After Vaccination: Non-inferiority
H3N2
|
40.1 Percentage of participants
Interval 36.9 to 43.3
|
—
|
—
|
65.7 Percentage of participants
Interval 63.5 to 67.8
|
|
Cohort 2: Percentage of Participants and Difference in Percentage of Participants With Strain-Specific HAI Seroconversion at 4 Weeks After Vaccination: Non-inferiority
Victoria
|
45.4 Percentage of participants
Interval 42.2 to 48.6
|
—
|
—
|
31.7 Percentage of participants
Interval 29.6 to 33.8
|
PRIMARY outcome
Timeframe: At 4 Weeks after VaccinationPopulation: EIP: eligible participants, received study intervention per randomization, had minimum 1 valid and determinate immunogenicity result from blood sample collected within 27- 42 days postvaccination, and had no major protocol violations. EIP for SARS-CoV-2 neutralization of Cohort 2 was utilized. Here "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 \*LLOQ. GMTs were reported in the descriptive data section of this outcome measure. GMRs were reported in the statistical analysis section.
Outcome measures
| Measure |
Cohort 3, Arm F: COVID-19 Vaccine
n=1480 Participants
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm G: Licensed Influenza Vaccine
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm H: Investigational Influenza Vaccine
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
|
Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo
n=2941 Participants
Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination A) and placebo, intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Cohort 2: GMT and GMR of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Neutralizing Titers at 4 Weeks After Vaccination: Non-inferiority
|
3476.6 Titer
Interval 3256.7 to 3711.4
|
—
|
—
|
3535.1 Titer
Interval 3370.0 to 3708.4
|
PRIMARY outcome
Timeframe: At 4 Weeks after VaccinationPopulation: EIP: eligible participants, received study intervention per randomization, had minimum 1 valid and determinate immunogenicity result from blood sample collected within 27- 42 days postvaccination, and had no major protocol violations. EIP for SARS-CoV-2 neutralization of Cohort 2 was utilized. Here "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Seroresponse was defined as achieving a postvaccination \>=4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of \>=4\*LLOQ was considered seroresponse. Percentage of participants with seroresponse were reported in the descriptive data section of this outcome measure. Difference in percentage of participants with seroresponse were reported in the statistical analysis section.
Outcome measures
| Measure |
Cohort 3, Arm F: COVID-19 Vaccine
n=1473 Participants
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm G: Licensed Influenza Vaccine
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm H: Investigational Influenza Vaccine
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
|
Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo
n=2932 Participants
Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination A) and placebo, intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Cohort 2: Percentage of Participants and Difference in Percentage of Participants With SARS-CoV-2 Seroresponse at 4 Weeks After Vaccination: Non-inferiority
|
73.7 Percentage of participants
Interval 71.4 to 76.0
|
—
|
—
|
75.5 Percentage of participants
Interval 73.9 to 77.1
|
SECONDARY outcome
Timeframe: At 4 Weeks after VaccinationPopulation: EIP:eligible participants, received study intervention per randomization, had minimum 1 valid and determinate immunogenicity result from blood sample collected within 27- 42 days postvaccination, and had no major protocol violations. EIP for HAI of Cohort 3 was utilized. "Overall Number of Participants Analyzed": participants evaluable for this outcome; "Number Analyzed": participants evaluable at specific strains. Per plan only those arms where influenza vaccine was administered were evaluated.
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 \*LLOQ. GMTs were reported in the descriptive data section of this outcome measure. GMRs were reported in the statistical analysis section. Data was reported for reported for following strains: H1N1, H3N2 and Victoria.
Outcome measures
| Measure |
Cohort 3, Arm F: COVID-19 Vaccine
n=579 Participants
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm G: Licensed Influenza Vaccine
n=580 Participants
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm H: Investigational Influenza Vaccine
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
|
Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo
n=1132 Participants
Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination A) and placebo, intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Cohort 3: GMT and GMR of Strain-Specific HAI Titers at 4 Weeks After Vaccination: Non-inferiority
H1N1
|
142.5 Titer
Interval 126.9 to 160.0
|
170.2 Titer
Interval 153.2 to 189.2
|
—
|
165.6 Titer
Interval 153.5 to 178.7
|
|
Cohort 3: GMT and GMR of Strain-Specific HAI Titers at 4 Weeks After Vaccination: Non-inferiority
H3N2
|
100.1 Titer
Interval 90.9 to 110.3
|
190.4 Titer
Interval 173.4 to 209.2
|
—
|
175.7 Titer
Interval 165.3 to 186.8
|
|
Cohort 3: GMT and GMR of Strain-Specific HAI Titers at 4 Weeks After Vaccination: Non-inferiority
Victoria
|
67.4 Titer
Interval 61.1 to 74.3
|
31.5 Titer
Interval 28.6 to 34.6
|
—
|
39.2 Titer
Interval 36.6 to 42.1
|
SECONDARY outcome
Timeframe: At 4 Weeks after VaccinationPopulation: EIP: eligible participants, received study intervention per randomization, had minimum 1 valid and determinate immunogenicity result from blood sample collected within 27-42 days postvaccination, and had no major protocol violations. EIP for SARS-CoV-2 neutralization of Cohort 3 was utilized. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure. Per plan only those arms where COVID-19 vaccine was administered were evaluated.
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 \*LLOQ. GMTs were reported in the descriptive data section of this outcome measure. GMRs were reported in the statistical analysis section.
Outcome measures
| Measure |
Cohort 3, Arm F: COVID-19 Vaccine
n=1135 Participants
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm G: Licensed Influenza Vaccine
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm H: Investigational Influenza Vaccine
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
|
Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo
n=1120 Participants
Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination A) and placebo, intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Cohort 3: GMT and GMR of SARS-CoV-2 Neutralizing Titers at 4 Weeks After Vaccination: Non-inferiority
|
4208.9 Titer
Interval 3901.8 to 4540.2
|
—
|
—
|
3841.0 Titer
Interval 3577.3 to 4124.1
|
Adverse Events
Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo
Serious events: 2 serious events
Other events: 245 other events
Deaths: 1 deaths
Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration
Serious events: 4 serious events
Other events: 113 other events
Deaths: 0 deaths
Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo
Serious events: 23 serious events
Other events: 2521 other events
Deaths: 2 deaths
Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration
Serious events: 22 serious events
Other events: 1152 other events
Deaths: 1 deaths
Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B)
Serious events: 10 serious events
Other events: 941 other events
Deaths: 1 deaths
Cohort 3, Arm F: COVID-19 Vaccine
Serious events: 15 serious events
Other events: 843 other events
Deaths: 0 deaths
Cohort 3, Arm G: Licensed Influenza Vaccine
Serious events: 5 serious events
Other events: 330 other events
Deaths: 1 deaths
Cohort 3, Arm H: Investigational Influenza Vaccine
Serious events: 7 serious events
Other events: 456 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo
n=309 participants at risk
Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination A) and placebo, intramuscularly on Day 1.
|
Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration
n=159 participants at risk
Participants 18 to 64 years of age were administered concomitantly with COVID-19 vaccine and licensed influenza vaccine administered, intramuscularly on Day 1.
|
Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo
n=3127 participants at risk
Participants 18 to 64 years of age were administered with Influenza and COVID-19 vaccine (combination B) and placebo, intramuscularly on Day 1.
|
Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration
n=1563 participants at risk
Participants 18 to 64 years of age were administered concomitantly with COVID-19 vaccine and licensed influenza vaccine administered, intramuscularly on Day 1.
|
Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B)
n=1189 participants at risk
Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination B), intramuscularly on Day 1.
|
Cohort 3, Arm F: COVID-19 Vaccine
n=1191 participants at risk
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm G: Licensed Influenza Vaccine
n=605 participants at risk
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm H: Investigational Influenza Vaccine
n=607 participants at risk
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.06%
1/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Cardiac disorders
Acute cardiac event
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.16%
1/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.17%
1/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.17%
1/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.06%
1/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.17%
1/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.06%
1/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Chest pain
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.06%
1/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.06%
1/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.06%
1/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.06%
1/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.06%
1/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Beta haemolytic streptococcal infection
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.16%
1/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Device related bacteraemia
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.63%
1/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Herpes zoster meningitis
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Incision site cellulitis
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.06%
1/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.06%
1/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Meningitis bacterial
|
0.32%
1/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.17%
2/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.13%
2/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.06%
1/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Renal abscess
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.63%
1/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Sepsis
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.06%
1/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.16%
1/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Septic shock
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.63%
1/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Wound infection
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.06%
1/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.17%
1/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.06%
1/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.17%
1/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.06%
1/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.13%
2/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.17%
1/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.16%
1/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.63%
1/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.06%
1/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.06%
1/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.16%
1/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.06%
1/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.63%
1/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal cord neoplasm
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Nervous system disorders
Brain stem stroke
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.17%
1/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.06%
1/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Nervous system disorders
Seizure
|
0.32%
1/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.13%
2/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.16%
1/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Nervous system disorders
Seizure like phenomena
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Nervous system disorders
Syncope
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.17%
1/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.06%
1/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.06%
1/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.06%
1/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.16%
1/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.16%
1/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.06%
1/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.13%
2/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.17%
1/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.06%
1/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.63%
1/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Vascular disorders
Hypertension
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.03%
1/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.63%
1/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.08%
1/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
Other adverse events
| Measure |
Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo
n=309 participants at risk
Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination A) and placebo, intramuscularly on Day 1.
|
Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration
n=159 participants at risk
Participants 18 to 64 years of age were administered concomitantly with COVID-19 vaccine and licensed influenza vaccine administered, intramuscularly on Day 1.
|
Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo
n=3127 participants at risk
Participants 18 to 64 years of age were administered with Influenza and COVID-19 vaccine (combination B) and placebo, intramuscularly on Day 1.
|
Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration
n=1563 participants at risk
Participants 18 to 64 years of age were administered concomitantly with COVID-19 vaccine and licensed influenza vaccine administered, intramuscularly on Day 1.
|
Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B)
n=1189 participants at risk
Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination B), intramuscularly on Day 1.
|
Cohort 3, Arm F: COVID-19 Vaccine
n=1191 participants at risk
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm G: Licensed Influenza Vaccine
n=605 participants at risk
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
|
Cohort 3, Arm H: Investigational Influenza Vaccine
n=607 participants at risk
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
0.32%
1/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
1.3%
2/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.48%
15/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.64%
10/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.17%
2/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.17%
2/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.50%
3/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.3%
4/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
1.9%
3/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.48%
15/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
1.1%
17/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.25%
3/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.50%
6/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.17%
1/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.49%
3/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Chills (CHILLS)
|
37.9%
117/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
16.4%
26/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
37.2%
1163/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
18.9%
295/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
27.5%
327/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
12.1%
144/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
6.6%
40/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
21.9%
133/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Fatigue (FATIGUE)
|
58.3%
180/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
41.5%
66/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
56.9%
1780/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
45.1%
705/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
51.3%
610/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
37.6%
448/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
30.7%
186/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
47.6%
289/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Injection site erythema (REDNESS)
|
14.2%
44/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
6.9%
11/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
9.4%
293/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
6.6%
103/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
10.3%
122/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
7.1%
84/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
3.0%
18/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
7.6%
46/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Injection site pain (PAIN)
|
73.5%
227/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
58.5%
93/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
72.2%
2259/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
62.4%
976/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
72.4%
861/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
61.5%
732/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
32.9%
199/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
65.2%
396/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Injection site swelling (SWELLING)
|
12.9%
40/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
7.5%
12/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
12.0%
376/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
7.8%
122/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
12.7%
151/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
8.5%
101/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
3.3%
20/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
10.2%
62/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Pyrexia (FEVER)
|
13.9%
43/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
2.5%
4/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
10.6%
331/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
4.5%
71/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
10.3%
123/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
2.5%
30/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
0.99%
6/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
5.8%
35/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Gastrointestinal disorders
Diarrhoea (DIARRHEA)
|
14.6%
45/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
13.8%
22/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
14.3%
446/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
13.2%
207/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
13.8%
164/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
11.8%
140/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
10.6%
64/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
12.7%
77/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Gastrointestinal disorders
Vomiting (VOMITING)
|
3.9%
12/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
1.9%
3/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
3.9%
123/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
3.1%
48/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
4.3%
51/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
2.5%
30/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
2.0%
12/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
2.0%
12/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN)
|
24.9%
77/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
11.3%
18/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
20.5%
640/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
13.6%
212/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
18.5%
220/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
10.7%
128/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
7.4%
45/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
15.5%
94/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (MUSCLE PAIN)
|
36.9%
114/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
14.5%
23/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
34.6%
1081/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
23.5%
368/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
29.9%
356/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
18.0%
214/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
10.2%
62/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
27.5%
167/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
|
Nervous system disorders
Headache (HEADACHE)
|
47.6%
147/309 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
29.6%
47/159 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
44.9%
1403/3127 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
33.1%
517/1563 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
41.1%
489/1189 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
28.8%
343/1191 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
24.0%
145/605 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
|
32.5%
197/607 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the 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