Trial Outcomes & Findings for A Study to Evaluate a Modified RNA Vaccine Against Influenza in Adults 18 Years of Age or Older (NCT NCT05540522)
NCT ID: NCT05540522
Last Updated: 2025-05-08
Results Overview
LCI was defined as influenza infection confirmed through through reverse transcription- polymerase chain reaction (RT-PCR) or culture at the central laboratory, unless otherwise specified. Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptoms concurrently with at least 1 systemic symptoms. Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
COMPLETED
PHASE3
45789 participants
Day 15 to surveillance cut-off (approximately 6 months)
2025-05-08
Participant Flow
Participants from northern hemisphere 2022-2023 and southern hemisphere 2023 were to be enrolled during respective influenza seasons and were stratified into 2 age groups: 18 to 64 years and more than or equal to (\>=) 65 years.
Participant milestones
| Measure |
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of quadrivalent influenza modified ribonucleic acid (modRNA) vaccine (qIRV) dose level 1 (low) intramuscularly (IM) on Day 1.
|
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed quadrivalent influenza vaccine (QIV) IM per investigational product manual (IPM) on Day 1.
|
qIRV: >=65 Years
Participants aged \>=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
|
Licensed QIV: >=65 Years
Participants aged \>=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9247
|
9251
|
13635
|
13656
|
|
Overall Study
Safety Set
|
9191
|
9197
|
13557
|
13611
|
|
Overall Study
COMPLETED
|
8527
|
8598
|
13026
|
13043
|
|
Overall Study
NOT COMPLETED
|
720
|
653
|
609
|
613
|
Reasons for withdrawal
| Measure |
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of quadrivalent influenza modified ribonucleic acid (modRNA) vaccine (qIRV) dose level 1 (low) intramuscularly (IM) on Day 1.
|
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed quadrivalent influenza vaccine (QIV) IM per investigational product manual (IPM) on Day 1.
|
qIRV: >=65 Years
Participants aged \>=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
|
Licensed QIV: >=65 Years
Participants aged \>=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
2
|
5
|
|
Overall Study
Lost to Follow-up
|
487
|
427
|
146
|
166
|
|
Overall Study
Physician Decision
|
11
|
19
|
8
|
13
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
3
|
1
|
9
|
7
|
|
Overall Study
Withdrawal by Subject
|
168
|
134
|
331
|
322
|
|
Overall Study
Death
|
7
|
9
|
49
|
46
|
|
Overall Study
Not vaccinated
|
34
|
53
|
57
|
50
|
|
Overall Study
No longer meets eligibility criteria
|
0
|
0
|
3
|
2
|
|
Overall Study
Other (Unspecified)
|
8
|
10
|
4
|
2
|
Baseline Characteristics
A Study to Evaluate a Modified RNA Vaccine Against Influenza in Adults 18 Years of Age or Older
Baseline characteristics by cohort
| Measure |
qIRV: 18-64 Years
n=9191 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=9197 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
qIRV: >=65 Years
n=13557 Participants
Participants aged \>=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
|
Licensed QIV: >=65 Years
n=13611 Participants
Participants aged \>=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
Total
n=45556 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.9 Years
STANDARD_DEVIATION 13.05 • n=5 Participants
|
43.1 Years
STANDARD_DEVIATION 13.07 • n=7 Participants
|
70.9 Years
STANDARD_DEVIATION 4.91 • n=5 Participants
|
70.8 Years
STANDARD_DEVIATION 4.84 • n=4 Participants
|
59.6 Years
STANDARD_DEVIATION 16.44 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5395 Participants
n=5 Participants
|
5293 Participants
n=7 Participants
|
7649 Participants
n=5 Participants
|
7665 Participants
n=4 Participants
|
26002 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3796 Participants
n=5 Participants
|
3904 Participants
n=7 Participants
|
5908 Participants
n=5 Participants
|
5946 Participants
n=4 Participants
|
19554 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1961 Participants
n=5 Participants
|
1955 Participants
n=7 Participants
|
2041 Participants
n=5 Participants
|
2094 Participants
n=4 Participants
|
8051 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7152 Participants
n=5 Participants
|
7156 Participants
n=7 Participants
|
11409 Participants
n=5 Participants
|
11430 Participants
n=4 Participants
|
37147 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
78 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
358 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
73 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
221 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
372 Participants
n=5 Participants
|
350 Participants
n=7 Participants
|
1657 Participants
n=5 Participants
|
1691 Participants
n=4 Participants
|
4070 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
24 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
190 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1734 Participants
n=5 Participants
|
1753 Participants
n=7 Participants
|
2567 Participants
n=5 Participants
|
2562 Participants
n=4 Participants
|
8616 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6780 Participants
n=5 Participants
|
6759 Participants
n=7 Participants
|
8974 Participants
n=5 Participants
|
8992 Participants
n=4 Participants
|
31505 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
67 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
273 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
141 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
194 Participants
n=4 Participants
|
681 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 15 to surveillance cut-off (approximately 6 months)Population: Evaluable efficacy population included all participants who were eligible, received the study intervention to which they were randomized, and had no important protocol deviations, with surveillance starting at least 14 days after vaccination.
LCI was defined as influenza infection confirmed through through reverse transcription- polymerase chain reaction (RT-PCR) or culture at the central laboratory, unless otherwise specified. Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptoms concurrently with at least 1 systemic symptoms. Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=9118 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=9120 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting First Episode of LCI Cases With Associated Per-Protocol ILI Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years
|
0.63 Percentage of participants
|
0.95 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 15 up to primary surveillance cut-off (approximately 1 year)Population: Evaluable efficacy population analyzed.
LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptoms concurrently with at least 1 systemic symptoms. Data was obtained during the 2022-2023 northern and southern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=13392 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=13456 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting First Episode of Laboratory-Confirmed Influenza (LCI) Cases With Associated Per-Protocol Influenza-Like Illness (ILI) Caused by Any Strain at Least 14 Days After Vaccination: >= 65 Years
|
0.59 Percentage of participants
|
0.56 Percentage of participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after study vaccinationPopulation: Reactogenicity e-diary safety included all participants who received the study intervention and had at least 1 day of e-diary data transferred for reactogenicity.
Local reactions included redness, swelling and pain at the injection site and were recorded by participants in an e-diary. All local reactions were graded based on Center for Biologics Evaluation and Research (CBER) toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure data is reported for any local reaction and any grade.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=3060 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=3067 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting Any Local Reactions Within 7 Days After Study Vaccination: 18-64 Years
|
70.1 Percentage of participants
Interval 68.5 to 71.7
|
43.1 Percentage of participants
Interval 41.3 to 44.9
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after study vaccinationPopulation: Reactogenicity e-diary safety set analyzed.
Local reactions included redness, swelling and pain at the injection site and were recorded by participants in an e-diary. All local reactions were graded based on Center for Biologics Evaluation and Research (CBER) toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure data is reported for any local reaction and any grade.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=3563 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=3563 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting Any Local Reactions Within 7 Days After Study Vaccination: >=65 Years
|
68.7 Percentage of participants
Interval 67.2 to 70.3
|
25.8 Percentage of participants
Interval 24.4 to 27.3
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after study vaccinationPopulation: Reactogenicity e-diary safety set analyzed.
Systemic events (vomiting, diarrhoea, headache, Fatigue/tiredness, chills, new or worsened muscle pain and joint pain) were recorded by participants in an e-diary. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure data is reported for any systemic reaction and any grade.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=3060 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=3067 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting Any Systemic Events Within 7 Days After Study Vaccination: 18-64 Years
|
65.8 Percentage of participants
Interval 64.0 to 67.4
|
48.7 Percentage of participants
Interval 46.9 to 50.5
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after study vaccinationPopulation: Reactogenicity e-diary safety set analyzed.
Systemic events (vomiting, diarrhoea, headache, Fatigue/tiredness, chills, new or worsened muscle pain and joint pain) were recorded by participants in an e-diary. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure data is reported for any systemic reaction and any grade.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=3563 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=3563 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting Any Systemic Events Within 7 Days After Study Vaccination: >=65 Years
|
58.6 Percentage of participants
Interval 57.0 to 60.2
|
34.9 Percentage of participants
Interval 33.3 to 36.4
|
PRIMARY outcome
Timeframe: From study vaccination on Day 1 through 4 weeks after study vaccinationPopulation: Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
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. Results excluded local reactions and systemic events data.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=9191 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=9197 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting Adverse Events (AEs) From Study Vaccination Through 4 Weeks After Study Vaccination: 18-64 Years
|
6.7 Percentage of participants
Interval 6.2 to 7.3
|
4.9 Percentage of participants
Interval 4.5 to 5.4
|
PRIMARY outcome
Timeframe: From study vaccination on Day 1 through 4 weeks after study vaccinationPopulation: Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
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. Results excluded local reactions and systemic events data.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=13557 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=13611 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting AEs From Study Vaccination Through 4 Weeks After Study Vaccination: >=65 Years
|
8.7 Percentage of participants
Interval 8.2 to 9.1
|
5.9 Percentage of participants
Interval 5.5 to 6.3
|
PRIMARY outcome
Timeframe: From study vaccination on Day 1 through 4 weeks after study vaccinationPopulation: Analysis population included all participants who received the study intervention. Data was planned to be analyzed in participants aged \>=18 years (combined for 18-64 years and \>65 years) as pre-specified in the protocol. The analysis includes participants who received qIRV at either dose level, as well as QIV.
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. Results excluded local reactions and systemic events data.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=22787 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=22808 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting AEs From Study Vaccination Through 4 Weeks After Study Vaccination: >=18 Years
|
7.9 Percentage of participants
Interval 7.5 to 8.2
|
5.5 Percentage of participants
Interval 5.2 to 5.8
|
PRIMARY outcome
Timeframe: From Day 1 up to 6 months after vaccinationPopulation: Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=9191 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=9197 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting Serious Adverse Events (SAEs) From Study Vaccination Through 6 Months After Study Vaccination: 18-64 Years
|
0.9 Percentage of participants
Interval 0.7 to 1.1
|
1.0 Percentage of participants
Interval 0.8 to 1.2
|
PRIMARY outcome
Timeframe: From Day 1 up to 6 months after vaccinationPopulation: Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=13557 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=13611 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting SAEs From Study Vaccination Through 6 Months After Study Vaccination: >=65 Years
|
2.3 Percentage of participants
Interval 2.1 to 2.6
|
2.2 Percentage of participants
Interval 1.9 to 2.4
|
PRIMARY outcome
Timeframe: From Day 1 up to 6 months after vaccinationPopulation: Analysis population included all participants who received the study intervention. Data was planned to be analyzed in participants aged \>=18 years (combined for 18-64 years and \>65 years) as pre-specified in the protocol. The analysis includes participants who received qIRV at either dose level, as well as QIV.
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=22787 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=22808 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting SAEs From Study Vaccination Through 6 Months After Study Vaccination: >=18 Years
|
1.8 Percentage of participants
Interval 1.6 to 1.9
|
1.7 Percentage of participants
Interval 1.5 to 1.9
|
SECONDARY outcome
Timeframe: Day 15 to surveillance cut-off (approximately 6 months)Population: Evaluable efficacy population analyzed.
LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=9118 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=9120 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting First Episode of LCI Cases With Associated Per-Protocol ILI Caused by All Matched Strains at Least 14 Days After Vaccination: 18-64 Years
|
0.23 Percentage of participants
|
0.34 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 15 up to primary surveillance cut-off (approximately 1 year)Population: Evaluable efficacy population analyzed.
LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. Data was obtained during the 2022-2023 northern and southern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=13392 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=13456 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting First Episode of LCI Cases With Associated Per-Protocol ILI Caused by All Matched Strains at Least 14 Days After Vaccination: >=65 Years
|
0.34 Percentage of participants
|
0.36 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 15 to surveillance cut-off (approximately 6 months)Population: Evaluable efficacy population analyzed.
CCI was defined as influenza infection confirmed through culture at the central laboratory, unless otherwise specified. Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptom concurrently with at least 1 systemic symptom. Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=9118 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=9120 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting First Episode of Culture Confirmed Influenza (CCI) With Associated Per-Protocol ILI Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years
|
0.23 Percentage of participants
|
0.34 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 15 up to primary surveillance cut-off (approximately 1 year)Population: Evaluable efficacy population analyzed.
CCI was defined as influenza infection confirmed through culture at the central laboratory, unless otherwise specified. Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptom concurrently with at least 1 systemic symptom. Data was obtained during the 2022-2023 northern and southern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=13392 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=13456 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting First Episode of CCI With Associated Per-Protocol ILI Caused by Any Strain at Least 14 Days After Vaccination: >=65 Years
|
0.34 Percentage of participants
|
0.36 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 15 to surveillance cut-off (approximately 6 months)Population: Evaluable efficacy population analyzed.
LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=9118 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=9120 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting First Episode of LCI Cases With Associated ILI as Defined by Modified Centers for Disease Control and Prevention (CDC) Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years
|
0.46 Percentage of participants
|
0.61 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 15 up to primary surveillance cut-off (approximately 1 year)Population: Evaluable efficacy population analyzed.
LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. ILI defined modified CDC: occurrence (new onset or worsening of preexisting condition) of at least 1 of the following respiratory symptoms concurrently with an oral temperature \>37.2 deg C (\>99.0 deg F), sore throat or cough. Data was obtained during the 2022-2023 northern and southern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=13392 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=13456 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting First Episode of LCI Cases With Associated ILI as Defined by Modified CDC Caused by Any Strain at Least 14 Days After Vaccination: >=65 Years
|
0.36 Percentage of participants
|
0.30 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 15 to surveillance cut-off (approximately 6 months)Population: Evaluable efficacy population analyzed.
LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. ILI as per WHO was defined as occurrence (new onset or worsening of preexisting condition) of a cough concurrently with an oral temperature \>=38.0 deg C (\>= 100.4 deg F). Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=9118 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=9120 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting First Episode of LCI Cases With Associated ILI as Defined by World Health Organization (WHO) Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years
|
0.27 Percentage of participants
|
0.35 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 15 up to primary surveillance cut-off (approximately 1 year)Population: Evaluable efficacy population analyzed.
LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. ILI as per WHO was defined as occurrence (new onset or worsening of preexisting condition) of a cough concurrently with an oral temperature \>=38.0 deg C (\>= 100.4 deg F). Data was obtained during the 2022-2023 northern and southern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=13392 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=13456 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting First Episode of LCI Cases With Associated ILI as Defined by WHO Caused by Any Strain at Least 14 Days After Vaccination: >=65 Years
|
0.23 Percentage of participants
|
0.22 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 15 to surveillance cut-off (approximately 6 months)Population: Evaluable efficacy population analyzed.
Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptom concurrently with at least 1 systemic symptom. Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=9118 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=9120 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting First Episode Cases of Influenza as Confirmed by RT-PCR or Local RT-PCR or Culture, With Associated Per-Protocol ILI at Least 14 Days After Vaccination: 18-64 Years
|
0.66 Percentage of participants
|
0.98 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 15 up to primary surveillance cut-off (approximately 1 year)Population: Evaluable efficacy population analyzed.
Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptom concurrently with at least 1 systemic symptom. Data was obtained during the 2022-2023 northern and southern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=13392 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=13456 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting First Episode Cases of Influenza as Confirmed by Central RT-PCR or Local RT-PCR or Culture, With Associated Per-Protocol ILI at Least 14 Days After Vaccination: >=65 Years
|
0.65 Percentage of participants
|
0.62 Percentage of participants
|
SECONDARY outcome
Timeframe: 4 Weeks after vaccinationPopulation: Evaluable immunogenicity set (Based on HAI Assay 2): eligible participants, received study intervention to which they were randomized, had blood drawn for assay testing within specified time frame, had at least 1 valid, determinate assay result (HAIs determinate assay 2) at 4-week postvaccination, no important protocol deviations. All participants reported under "N" contributed data to table but may not have evaluable data for every row. "n"=number of participants evaluable for specified rows.
Geometric mean titers (GMTs) and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution) and were reported in the descriptive section. Geometric mean ratios (GMRs) were estimated by the ratio of the GMTs between qIRV recipients compared to licensed QIV recipients vaccine groups and were reported in the statistical analysis section.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=739 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=746 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV at 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
A/H3N2
|
222.3 Titers
Interval 206.0 to 240.0
|
180.4 Titers
Interval 166.6 to 195.4
|
|
HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV at 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
A/H1N1
|
397.7 Titers
Interval 367.8 to 430.0
|
321.7 Titers
Interval 294.6 to 351.2
|
|
HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV at 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
B/Yamagata
|
84.5 Titers
Interval 79.4 to 90.0
|
115.9 Titers
Interval 108.5 to 123.8
|
|
HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV at 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
B/Victoria
|
21.3 Titers
Interval 19.3 to 23.6
|
70.6 Titers
Interval 63.6 to 78.4
|
SECONDARY outcome
Timeframe: 4 Weeks after vaccinationPopulation: Evaluable immunogenicity set (Based on HAI Assay 2) analyzed. All participants reported under "Number of Participants Analyzed" contributed data to the table but may not have evaluable data for every row. Here, "Number analyzed" signifies number of participants evaluable for specified rows.
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution) and were reported in the descriptive section. GMRs were estimated by the ratio of the GMTs between qIRV recipients compared to licensed QIV recipients vaccine groups and were reported in the statistical analysis section.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=754 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=740 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination- Based on HAI Assay 2: >=65 Years
A/H3N2
|
296.0 Titers
Interval 273.7 to 320.1
|
179.8 Titers
Interval 166.3 to 194.5
|
|
HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination- Based on HAI Assay 2: >=65 Years
A/H1N1
|
240.0 Titers
Interval 220.3 to 261.3
|
140.6 Titers
Interval 129.2 to 152.9
|
|
HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination- Based on HAI Assay 2: >=65 Years
B/Yamagata
|
57.6 Titers
Interval 54.1 to 61.2
|
55.3 Titers
Interval 52.0 to 58.9
|
|
HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination- Based on HAI Assay 2: >=65 Years
B/Victoria
|
82.1 Titers
Interval 75.0 to 89.9
|
134.8 Titers
Interval 123.5 to 147.3
|
SECONDARY outcome
Timeframe: 4 Weeks after vaccinationPopulation: Evaluable immunogenicity set (Based on HAI Assay 2) analyzed. Here, Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row and "Number Analyzed" signifies number of participants evaluable for specified rows.
Seroconversion was defined as an HAI titer \<1:10 prior to vaccination and \>=1:40 at the time point of interest, or an HAI titer of \>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Percentage of participants achieving seroconversion for each strain at 4 weeks after vaccination and exact 2-sided 95% CI is presented in the descriptive section. Difference in percentage of participants (qIRV - QIV) achieving HAI seroconversion for each strain at 4 weeks after vaccination is presented in the statistical analysis section.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=739 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=746 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
A/H3N2
|
64.2 Percentage of Participants
Interval 60.6 to 67.7
|
52.8 Percentage of Participants
Interval 49.2 to 56.4
|
|
Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
A/H1N1
|
66.1 Percentage of Participants
Interval 62.6 to 69.5
|
52.5 Percentage of Participants
Interval 48.8 to 56.1
|
|
Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
B/Yamagata
|
13.9 Percentage of Participants
Interval 11.4 to 16.6
|
29.2 Percentage of Participants
Interval 26.0 to 32.6
|
|
Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
B/Victoria
|
11.4 Percentage of Participants
Interval 9.1 to 13.9
|
51.8 Percentage of Participants
Interval 48.2 to 55.5
|
SECONDARY outcome
Timeframe: 4 Weeks after vaccinationPopulation: Evaluable immunogenicity set (Based on HAI Assay 2) analyzed. Here, Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row and "Number Analyzed" signifies number of participants evaluable for specified rows.
Seroconversion was defined as an HAI titer \<1:10 prior to vaccination and \>=1:40 at the time point of interest, or an HAI titer of \>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Percentage of participants achieving seroconversion for each strain at 4 weeks after vaccination and exact 2-sided 95% CI is presented in the descriptive section. Difference in percentage of participants (qIRV - QIV) achieving HAI seroconversion for each strain at 4 weeks after vaccination is presented in the statistical analysis section.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=754 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=740 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years
A/H3N2
|
53.2 Percentage of participants
Interval 49.6 to 56.8
|
31.6 Percentage of participants
Interval 28.2 to 35.1
|
|
Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years
A/H1N1
|
50.2 Percentage of participants
Interval 46.6 to 53.8
|
24.5 Percentage of participants
Interval 21.4 to 27.8
|
|
Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years
B/Yamagata
|
6.4 Percentage of participants
Interval 4.8 to 8.4
|
8.5 Percentage of participants
Interval 6.6 to 10.7
|
|
Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years
B/Victoria
|
10.9 Percentage of participants
Interval 8.8 to 13.4
|
33.5 Percentage of participants
Interval 30.1 to 37.1
|
SECONDARY outcome
Timeframe: 4 Weeks after vaccinationPopulation: Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
GMTs and 2-sided 95% CIs were reported in the descriptive section. GMRs were estimated by the ratio of the GMTs between qIRV recipients compared to licensed QIV recipients vaccine groups and were reported in the statistical analysis section.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=1867 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=1871 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination- Based on HAI Assay 1: 18-64 Years
A/H3N2
|
117.3 Titers
Interval 111.2 to 123.6
|
61.1 Titers
Interval 57.8 to 64.5
|
|
HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination- Based on HAI Assay 1: 18-64 Years
A/H1N1
|
203.7 Titers
Interval 193.3 to 214.8
|
121.2 Titers
Interval 114.1 to 128.8
|
|
HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination- Based on HAI Assay 1: 18-64 Years
B/Yamagata
|
55.0 Titers
Interval 52.6 to 57.5
|
62.4 Titers
Interval 59.4 to 65.5
|
|
HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination- Based on HAI Assay 1: 18-64 Years
B/Victoria
|
16.7 Titers
Interval 15.8 to 17.6
|
28.7 Titers
Interval 27.0 to 30.6
|
SECONDARY outcome
Timeframe: 4 Weeks after vaccinationPopulation: Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed" signifies participants evaluable for rows.
GMTs and 2-sided 95% CIs were reported in the descriptive section. GMRs were estimated by the ratio of the GMTs between qIRV recipients compared to licensed QIV recipients vaccine groups and were reported in the statistical analysis section.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=2447 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=2441 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination - Based on HAI Assay 1: >=65 Years
A/H1N1
|
131.8 Titers
Interval 125.9 to 138.0
|
55.6 Titers
Interval 52.8 to 58.5
|
|
HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination - Based on HAI Assay 1: >=65 Years
A/H3N2
|
98.2 Titers
Interval 93.9 to 102.8
|
41.3 Titers
Interval 39.4 to 43.3
|
|
HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination - Based on HAI Assay 1: >=65 Years
B/Yamagata
|
38.9 Titers
Interval 37.5 to 40.3
|
28.6 Titers
Interval 27.6 to 29.7
|
|
HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination - Based on HAI Assay 1: >=65 Years
B/Victoria
|
40.1 Titers
Interval 38.4 to 41.8
|
52.9 Titers
Interval 50.4 to 55.5
|
SECONDARY outcome
Timeframe: 4 Weeks after vaccinationPopulation: Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Seroconversion was defined as an HAI titer \<1:10 prior to vaccination and \>=1:40 at the time point of interest, or an HAI titer of \>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Percentage of participants achieving seroconversion for each strain at 4 weeks after vaccination and exact 2-sided 95% CI is presented in the descriptive section. Difference in percentage of participants (qIRV - QIV) achieving HAI seroconversion for each strain at 4 weeks after vaccination is presented in the statistical analysis section.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=1867 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=1871 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere-Based on HAI Assay 1: 18-64 Years
A/H3N2
|
73.1 Percentage of participants
Interval 71.0 to 75.1
|
46.3 Percentage of participants
Interval 44.0 to 48.6
|
|
Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere-Based on HAI Assay 1: 18-64 Years
A/H1N1
|
78.3 Percentage of participants
Interval 76.4 to 80.2
|
51.4 Percentage of participants
Interval 49.1 to 53.8
|
|
Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere-Based on HAI Assay 1: 18-64 Years
B/Yamagata
|
30.0 Percentage of participants
Interval 27.9 to 32.1
|
33.5 Percentage of participants
Interval 31.4 to 35.7
|
|
Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere-Based on HAI Assay 1: 18-64 Years
B/Victoria
|
13.5 Percentage of participants
Interval 12.0 to 15.2
|
32.7 Percentage of participants
Interval 30.6 to 34.9
|
SECONDARY outcome
Timeframe: 4 Weeks after vaccinationPopulation: Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Seroconversion was defined as an HAI titer \<1:10 prior to vaccination and \>=1:40 at the time point of interest, or an HAI titer of \>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Percentage of participants achieving seroconversion for each strain at 4 weeks after vaccination and exact 2-sided 95% CI is presented in the descriptive section. Difference in percentage of participants (qIRV - QIV) achieving HAI seroconversion for each strain at 4 weeks after vaccination is presented in the statistical analysis section.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=2447 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=2441 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years
A/H3N2
|
66.0 Percentage of participants
Interval 64.0 to 67.9
|
28.1 Percentage of participants
Interval 26.3 to 30.0
|
|
Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years
A/H1N1
|
68.4 Percentage of participants
Interval 66.5 to 70.3
|
23.5 Percentage of participants
Interval 21.8 to 25.2
|
|
Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years
B/Yamagata
|
22.6 Percentage of participants
Interval 21.0 to 24.4
|
12.0 Percentage of participants
Interval 10.7 to 13.4
|
|
Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years
B/Victoria
|
19.8 Percentage of participants
Interval 18.2 to 21.4
|
33.6 Percentage of participants
Interval 31.7 to 35.5
|
SECONDARY outcome
Timeframe: Baseline (Before Vaccination)Population: Evaluable immunogenicity set (Based on HAI Assay 2) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=739 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=746 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
HAI GMTs at Baseline for the 2022-2023 Northern Hemisphere - Based on HAI Assay 2: 18-64 Years
A/H3N2
|
42.9 Titers
Interval 39.7 to 46.3
|
42.3 Titers
Interval 39.3 to 45.4
|
|
HAI GMTs at Baseline for the 2022-2023 Northern Hemisphere - Based on HAI Assay 2: 18-64 Years
A/H1N1
|
58.0 Titers
Interval 51.8 to 64.9
|
50.5 Titers
Interval 45.2 to 56.4
|
|
HAI GMTs at Baseline for the 2022-2023 Northern Hemisphere - Based on HAI Assay 2: 18-64 Years
B/Yamagata
|
49.2 Titers
Interval 45.9 to 52.8
|
46.2 Titers
Interval 43.0 to 49.6
|
|
HAI GMTs at Baseline for the 2022-2023 Northern Hemisphere - Based on HAI Assay 2: 18-64 Years
B/Victoria
|
13.0 Titers
Interval 11.9 to 14.2
|
13.5 Titers
Interval 12.4 to 14.8
|
SECONDARY outcome
Timeframe: Baseline (Before Vaccination)Population: Evaluable immunogenicity set (Based on HAI Assay 2) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=754 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=740 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years
A/H3N2
|
71.2 Titers
Interval 67.1 to 75.6
|
68.6 Titers
Interval 64.7 to 72.7
|
|
HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years
A/H1N1
|
60.2 Titers
Interval 54.4 to 66.6
|
58.3 Titers
Interval 52.8 to 64.4
|
|
HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years
B/Yamagata
|
38.7 Titers
Interval 36.5 to 41.1
|
36.8 Titers
Interval 34.5 to 39.2
|
|
HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years
B/Victoria
|
47.5 Titers
Interval 43.3 to 52.2
|
43.5 Titers
Interval 39.4 to 48.0
|
SECONDARY outcome
Timeframe: Before vaccination (Baseline) to 4 weeks after vaccinationPopulation: Evaluable immunogenicity set (Based on HAI Assay 2) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
GMFRs were defined as ratios of the results after vaccination to the results before vaccination (baseline).
Outcome measures
| Measure |
qIRV: 18-64 Years
n=739 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=746 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
HAI Geometric Mean Fold Rise (GMFR) From Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
A/H3N2
|
4.9 Fold rise
Interval 4.5 to 5.2
|
4.1 Fold rise
Interval 3.8 to 4.4
|
|
HAI Geometric Mean Fold Rise (GMFR) From Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
A/H1N1
|
6.0 Fold rise
Interval 5.5 to 6.6
|
5.6 Fold rise
Interval 5.0 to 6.2
|
|
HAI Geometric Mean Fold Rise (GMFR) From Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
B/Yamagata
|
1.7 Fold rise
Interval 1.6 to 1.8
|
2.4 Fold rise
Interval 2.2 to 2.5
|
|
HAI Geometric Mean Fold Rise (GMFR) From Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
B/Victoria
|
1.4 Fold rise
Interval 1.4 to 1.5
|
3.9 Fold rise
Interval 3.6 to 4.2
|
SECONDARY outcome
Timeframe: Before vaccination (Baseline) to 4 weeks after vaccinationPopulation: Evaluable immunogenicity set (Based on HAI Assay 2) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
GMFRs were defined as ratios of the results after vaccination to the results before vaccination (baseline).
Outcome measures
| Measure |
qIRV: 18-64 Years
n=754 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=740 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years
A/H3N2
|
4.2 Fold rise
Interval 3.9 to 4.4
|
2.6 Fold rise
Interval 2.5 to 2.8
|
|
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years
A/H1N1
|
3.7 Fold rise
Interval 3.4 to 3.9
|
2.2 Fold rise
Interval 2.0 to 2.4
|
|
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years
B/Yamagata
|
1.4 Fold rise
Interval 1.4 to 1.5
|
1.4 Fold rise
Interval 1.4 to 1.5
|
|
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years
B/Victoria
|
1.6 Fold rise
Interval 1.6 to 1.7
|
2.8 Fold rise
Interval 2.6 to 3.0
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks after vaccinationPopulation: Evaluable immunogenicity set (Based on HAI Assay 2) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=739 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=746 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
Baseline: A/H3N2
|
65.0 Percentage of participants
Interval 61.5 to 68.5
|
63.1 Percentage of participants
Interval 59.6 to 66.6
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
4 Weeks after vaccination: A/H3N2
|
99.2 Percentage of participants
Interval 98.2 to 99.7
|
96.5 Percentage of participants
Interval 94.9 to 97.7
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
Baseline: A/H1N1
|
68.0 Percentage of participants
Interval 64.5 to 71.4
|
63.5 Percentage of participants
Interval 59.9 to 67.0
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
4 Weeks after vaccination: A/H1N1
|
98.4 Percentage of participants
Interval 97.2 to 99.2
|
96.6 Percentage of participants
Interval 95.1 to 97.8
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
Baseline: B/Yamagata
|
71.3 Percentage of participants
Interval 67.9 to 74.6
|
69.3 Percentage of participants
Interval 65.9 to 72.6
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
4 Weeks after vaccination: B/Yamagata
|
88.7 Percentage of participants
Interval 86.2 to 90.9
|
93.0 Percentage of participants
Interval 90.9 to 94.7
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
Baseline: B/Victoria
|
25.7 Percentage of participants
Interval 22.6 to 29.0
|
24.6 Percentage of participants
Interval 21.5 to 27.8
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
4 Weeks after vaccination: B/Victoria
|
38.6 Percentage of participants
Interval 35.0 to 42.2
|
72.7 Percentage of participants
Interval 69.3 to 75.9
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks after vaccinationPopulation: Evaluable immunogenicity set (Based on HAI Assay 2) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=754 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=740 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years
Baseline: A/H3N2
|
84.5 Percentage of participants
Interval 81.7 to 87.0
|
85.6 Percentage of participants
Interval 82.8 to 88.0
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years
4 Weeks after vaccination: A/H3N2
|
99.6 Percentage of participants
Interval 98.8 to 99.9
|
97.3 Percentage of participants
Interval 95.8 to 98.3
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years
Baseline: A/H1N1
|
70.5 Percentage of participants
Interval 67.1 to 73.7
|
73.2 Percentage of participants
Interval 69.8 to 76.4
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years
4 Weeks after vaccination: A/H1N1
|
96.2 Percentage of participants
Interval 94.5 to 97.4
|
92.1 Percentage of participants
Interval 89.9 to 93.9
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years
Baseline: B/Yamagata
|
60.9 Percentage of participants
Interval 57.3 to 64.4
|
60.7 Percentage of participants
Interval 57.1 to 64.3
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years
4 Weeks after vaccination: B/Yamagata
|
77.3 Percentage of participants
Interval 74.1 to 80.3
|
75.0 Percentage of participants
Interval 71.7 to 78.1
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years
Baseline: B/Victoria
|
64.4 Percentage of participants
Interval 60.9 to 67.9
|
61.6 Percentage of participants
Interval 57.9 to 65.1
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years
4 Weeks after vaccination: B/Victoria
|
78.7 Percentage of participants
Interval 75.6 to 81.5
|
89.8 Percentage of participants
Interval 87.4 to 91.9
|
SECONDARY outcome
Timeframe: BaselinePopulation: Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=1867 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=1871 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years
B/Yamagata
|
22.7 Titers
Interval 21.6 to 23.8
|
22.7 Titers
Interval 21.6 to 23.9
|
|
HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years
A/H3N2
|
18.2 Titers
Interval 17.3 to 19.2
|
17.6 Titers
Interval 16.7 to 18.5
|
|
HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years
A/H1N1
|
22.7 Titers
Interval 21.4 to 24.1
|
23.1 Titers
Interval 21.8 to 24.5
|
|
HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years
B/Victoria
|
10.1 Titers
Interval 9.6 to 10.6
|
10.1 Titers
Interval 9.6 to 10.5
|
SECONDARY outcome
Timeframe: BaselinePopulation: Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=2447 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=2441 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
HAI GMTs at Baseline for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years
A/H3N2
|
19.7 Titers
Interval 18.9 to 20.6
|
19.0 Titers
Interval 18.2 to 19.8
|
|
HAI GMTs at Baseline for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years
A/H1N1
|
25.2 Titers
Interval 24.0 to 26.4
|
24.5 Titers
Interval 23.4 to 25.8
|
|
HAI GMTs at Baseline for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years
B/Yamagata
|
18.1 Titers
Interval 17.4 to 18.7
|
17.2 Titers
Interval 16.6 to 17.8
|
|
HAI GMTs at Baseline for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years
B/Victoria
|
20.0 Titers
Interval 19.1 to 20.9
|
19.7 Titers
Interval 18.8 to 20.6
|
SECONDARY outcome
Timeframe: Before vaccination (Baseline) to 4 weeks after vaccinationPopulation: Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
GMFRs were defined as ratios of the results after vaccination to the results before vaccination (baseline).
Outcome measures
| Measure |
qIRV: 18-64 Years
n=1867 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=1871 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: 18-64 Years
A/H3N2
|
5.4 Fold rise
Interval 5.1 to 5.6
|
2.9 Fold rise
Interval 2.8 to 3.1
|
|
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: 18-64 Years
A/H1N1
|
7.5 Fold rise
Interval 7.1 to 7.9
|
4.4 Fold rise
Interval 4.1 to 4.7
|
|
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: 18-64 Years
B/Yamagata
|
2.2 Fold rise
Interval 2.1 to 2.2
|
2.4 Fold rise
Interval 2.3 to 2.5
|
|
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: 18-64 Years
B/Victoria
|
1.4 Fold rise
Interval 1.4 to 1.5
|
2.2 Fold rise
Interval 2.1 to 2.3
|
SECONDARY outcome
Timeframe: Before vaccination (Baseline) to 4 weeks after vaccinationPopulation: Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
GMFRs were defined as ratios of the results after vaccination to the results before vaccination.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=2447 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=2441 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years
A/H3N2
|
4.2 Fold rise
Interval 4.1 to 4.4
|
1.9 Fold rise
Interval 1.9 to 2.0
|
|
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years
A/H1N1
|
4.5 Fold rise
Interval 4.4 to 4.7
|
2.0 Fold rise
Interval 1.9 to 2.1
|
|
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years
B/Yamagata
|
1.9 Fold rise
Interval 1.9 to 2.0
|
1.5 Fold rise
Interval 1.5 to 1.5
|
|
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years
B/Victoria
|
1.8 Fold rise
Interval 1.8 to 1.9
|
2.4 Fold rise
Interval 2.3 to 2.5
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks after vaccinationPopulation: Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=1867 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=1871 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years
Baseline: A/H3N2
|
36.8 Percentage of participants
Interval 34.6 to 39.1
|
35.2 Percentage of participants
Interval 33.0 to 37.4
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years
4 Weeks after vaccination: A/H3N2
|
91.1 Percentage of participants
Interval 89.7 to 92.4
|
75.8 Percentage of participants
Interval 73.7 to 77.7
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years
Baseline: A/H1N1
|
41.6 Percentage of participants
Interval 39.4 to 43.9
|
44.9 Percentage of participants
Interval 42.7 to 47.3
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years
4 Weeks after vaccination: A/H1N1
|
95.0 Percentage of participants
Interval 93.9 to 95.9
|
86.8 Percentage of participants
Interval 85.2 to 88.3
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years
Baseline: B/Yamagata
|
42.2 Percentage of participants
Interval 40.0 to 44.5
|
43.0 Percentage of participants
Interval 40.7 to 45.3
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years
4 Weeks after vaccination: B/Yamagata
|
75.3 Percentage of participants
Interval 73.2 to 77.2
|
76.7 Percentage of participants
Interval 74.7 to 78.6
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years
Baseline: B/Victoria
|
16.3 Percentage of participants
Interval 14.6 to 18.1
|
15.5 Percentage of participants
Interval 13.8 to 17.2
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years
4 Weeks after vaccination: B/Victoria
|
31.9 Percentage of participants
Interval 29.8 to 34.1
|
47.0 Percentage of participants
Interval 44.7 to 49.3
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks after vaccinationPopulation: Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=2447 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=2441 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: >=65 Years
Baseline: A/H3N2
|
40.4 Percentage of participants
Interval 38.4 to 42.4
|
37.6 Percentage of participants
Interval 35.6 to 39.6
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: >=65 Years
4 Weeks after vaccination: A/H3N2
|
88.3 Percentage of participants
Interval 87.0 to 89.6
|
64.6 Percentage of participants
Interval 62.7 to 66.5
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: >=65 Years
Baseline: A/H1N1
|
46.4 Percentage of participants
Interval 44.4 to 48.5
|
44.4 Percentage of participants
Interval 42.4 to 46.4
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: >=65 Years
4 Weeks after vaccination: A/H1N1
|
91.7 Percentage of participants
Interval 90.6 to 92.8
|
70.6 Percentage of participants
Interval 68.8 to 72.4
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: >=65 Years
Baseline: B/Yamagata
|
31.0 Percentage of participants
Interval 29.1 to 32.9
|
28.3 Percentage of participants
Interval 26.5 to 30.2
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: >=65 Years
4 Weeks after vaccination: B/Yamagata
|
65.1 Percentage of participants
Interval 63.2 to 67.0
|
50.2 Percentage of participants
Interval 48.2 to 52.2
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: >=65 Years
Baseline: B/Victoria
|
36.3 Percentage of participants
Interval 34.3 to 38.3
|
35.2 Percentage of participants
Interval 33.2 to 37.1
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: >=65 Years
4 Weeks after vaccination: B/Victoria
|
63.6 Percentage of participants
Interval 61.7 to 65.5
|
69.0 Percentage of participants
Interval 67.1 to 70.8
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks after vaccinationPopulation: As there was no participant from southern hemisphere aged 18-64 years, no data was collected for this outcome measure. Therefore, there was no analysis performed for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 4 weeks after vaccinationPopulation: Evaluable immunogenicity set (Based on HAI Assay 2) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=391 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=390 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years
4 Weeks after vaccination: A/H1N1
|
73.8 Titers
Interval 62.9 to 86.5
|
92.7 Titers
Interval 80.0 to 107.4
|
|
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years
Baseline: A/H3N2
|
84.1 Titers
Interval 77.1 to 91.8
|
82.9 Titers
Interval 76.1 to 90.2
|
|
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years
4 Weeks after vaccination: A/H3N2
|
460.9 Titers
Interval 414.8 to 512.0
|
272.2 Titers
Interval 244.3 to 303.3
|
|
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years
Baseline: A/H1N1
|
10.9 Titers
Interval 9.7 to 12.3
|
12.2 Titers
Interval 10.8 to 13.8
|
|
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years
Baseline: B/Yamagata
|
35.5 Titers
Interval 32.1 to 39.2
|
37.5 Titers
Interval 33.8 to 41.5
|
|
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years
4 Weeks after vaccination: B/Yamagata
|
70.0 Titers
Interval 64.0 to 76.5
|
81.4 Titers
Interval 74.5 to 88.9
|
|
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years
Baseline: B/Victoria
|
34.0 Titers
Interval 29.6 to 39.2
|
31.1 Titers
Interval 26.9 to 36.0
|
|
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years
4 Weeks after vaccination: B/Victoria
|
77.9 Titers
Interval 69.1 to 87.8
|
124.2 Titers
Interval 109.9 to 140.5
|
SECONDARY outcome
Timeframe: Before vaccination (Baseline) to 4 weeks after vaccinationPopulation: As there was no participant from southern hemisphere aged 18-64 years, no data was collected for this outcome measure. Therefore, there was no analysis performed for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Before vaccination (Baseline) to 4 weeks after vaccinationPopulation: Evaluable immunogenicity set (Based on HAI Assay 2) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
GMFRs were defined as ratios of the results after vaccination to the results before vaccination (baseline).
Outcome measures
| Measure |
qIRV: 18-64 Years
n=391 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=390 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years
A/H3N2
|
5.5 Fold rise
Interval 5.0 to 6.0
|
3.3 Fold rise
Interval 3.0 to 3.6
|
|
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years
A/H1N1
|
4.8 Fold rise
Interval 4.2 to 5.4
|
5.4 Fold rise
Interval 4.7 to 6.2
|
|
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years
B/Yamagata
|
1.8 Fold rise
Interval 1.7 to 2.0
|
2.0 Fold rise
Interval 1.9 to 2.2
|
|
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years
B/Victoria
|
2.0 Fold rise
Interval 1.9 to 2.2
|
3.3 Fold rise
Interval 3.0 to 3.8
|
SECONDARY outcome
Timeframe: 4 weeks after vaccinationPopulation: As there was no participant from southern hemisphere aged 18-64 years, no data was collected for this outcome measure. Therefore, there was no analysis performed for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeks after vaccinationPopulation: Evaluable immunogenicity set (Based on HAI Assay 2) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Seroconversion was defined as an HAI titer \<1:10 prior to vaccination and \>=1:40 at the time point of interest, or an HAI titer of \>=1:10 prior to vaccination with a 4-fold rise at the time point of interest.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=391 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=390 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years
A/H3N2
|
68.9 Percentage of participants
Interval 64.0 to 73.5
|
41.6 Percentage of participants
Interval 36.6 to 46.7
|
|
Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years
A/H1N1
|
58.5 Percentage of participants
Interval 53.4 to 63.5
|
58.7 Percentage of participants
Interval 53.6 to 63.7
|
|
Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years
B/Yamagata
|
16.3 Percentage of participants
Interval 12.8 to 20.4
|
21.6 Percentage of participants
Interval 17.6 to 26.0
|
|
Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years
B/Victoria
|
21.0 Percentage of participants
Interval 17.1 to 25.5
|
36.4 Percentage of participants
Interval 31.6 to 41.5
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks after vaccinationPopulation: As there was no participant from southern hemisphere aged 18-64 years, no data was collected for this outcome measure. Therefore, there was no analysis performed for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 4 weeks after vaccinationPopulation: Evaluable immunogenicity set (Based on HAI Assay 2) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=391 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=390 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years
Baseline: A/H3N2
|
93.8 Percentage of participants
Interval 90.9 to 96.0
|
94.0 Percentage of participants
Interval 91.2 to 96.2
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years
4 weeks after vaccination: A/H3N2
|
100.0 Percentage of participants
Interval 99.1 to 100.0
|
99.0 Percentage of participants
Interval 97.4 to 99.7
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years
Baseline: A/H1N1
|
19.8 Percentage of participants
Interval 16.0 to 24.2
|
23.6 Percentage of participants
Interval 19.4 to 28.1
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years
4 weeks after vaccination: A/H1N1
|
70.0 Percentage of participants
Interval 65.2 to 74.5
|
76.6 Percentage of participants
Interval 72.1 to 80.7
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years
Baseline: B/Yamagata
|
56.5 Percentage of participants
Interval 51.4 to 61.5
|
61.0 Percentage of participants
Interval 56.0 to 65.9
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years
4 weeks after vaccination: B/Yamagata
|
82.9 Percentage of participants
Interval 78.8 to 86.6
|
87.4 Percentage of participants
Interval 83.7 to 90.5
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years
Baseline: B/Victoria
|
54.8 Percentage of participants
Interval 49.7 to 59.9
|
50.8 Percentage of participants
Interval 45.7 to 55.9
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years
4 weeks after vaccination: B/Victoria
|
80.8 Percentage of participants
Interval 76.5 to 84.6
|
86.9 Percentage of participants
Interval 83.1 to 90.1
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks after vaccinationPopulation: As there was no participant from southern hemisphere aged 18-64 years, no data was collected for this outcome measure. Therefore, there was no analysis performed for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 4 weeks after vaccinationPopulation: Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=391 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=390 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
Baseline: A/H3N2
|
32.9 Titers
Interval 29.7 to 36.5
|
30.4 Titers
Interval 27.4 to 33.7
|
|
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
4 Weeks after vaccination: A/H3N2
|
224.0 Titers
Interval 199.2 to 252.0
|
96.8 Titers
Interval 86.2 to 108.7
|
|
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
Baseline: A/H1N1
|
14.8 Titers
Interval 13.1 to 16.7
|
15.0 Titers
Interval 13.3 to 17.0
|
|
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
4 Weeks after vaccination: A/H1N1
|
129.5 Titers
Interval 111.9 to 149.9
|
88.0 Titers
Interval 76.3 to 101.3
|
|
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
Baseline: B/Yamagata
|
16.1 Titers
Interval 14.7 to 17.6
|
16.1 Titers
Interval 14.7 to 17.6
|
|
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
4 Weeks after vaccination: B/Yamagata
|
40.4 Titers
Interval 37.2 to 43.7
|
38.0 Titers
Interval 34.6 to 41.9
|
|
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
Baseline: B/Victoria
|
20.4 Titers
Interval 18.3 to 22.9
|
19.6 Titers
Interval 17.5 to 22.0
|
|
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
4 Weeks after vaccination: B/Victoria
|
45.9 Titers
Interval 41.3 to 51.1
|
55.6 Titers
Interval 49.6 to 62.4
|
SECONDARY outcome
Timeframe: Before Vaccination (baseline) to 4 weeks after vaccinationPopulation: As there was no participant from southern hemisphere aged 18-64 years, no data was collected for this outcome measure. Therefore, there was no analysis performed for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Before vaccination (baseline) to 4 weeks after vaccinationPopulation: Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
GMFRs were defined as ratios of the results after vaccination to the results before vaccination (baseline).
Outcome measures
| Measure |
qIRV: 18-64 Years
n=391 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=390 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for the 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
A/H3N2
|
6.4 Fold rise
Interval 5.8 to 7.1
|
3.0 Fold rise
Interval 2.7 to 3.3
|
|
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for the 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
A/H1N1
|
6.8 Fold rise
Interval 6.0 to 7.6
|
4.5 Fold rise
Interval 4.0 to 5.1
|
|
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for the 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
B/Yamagata
|
2.2 Fold rise
Interval 2.1 to 2.3
|
2.1 Fold rise
Interval 1.9 to 2.3
|
|
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for the 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
B/Victoria
|
2.0 Fold rise
Interval 1.8 to 2.1
|
2.5 Fold rise
Interval 2.3 to 2.7
|
SECONDARY outcome
Timeframe: 4 weeks after vaccinationPopulation: As there was no participant from southern hemisphere aged 18-64 years, no data was collected for this outcome measure. Therefore, there was no analysis performed for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeks after vaccinationPopulation: Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Seroconversion was defined as an HAI titer \<1:10 prior to vaccination and \>=1:40 at the time point of interest, or an HAI titer of \>=1:10 prior to vaccination with a 4-fold rise at the time point of interest.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=391 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=390 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
A/H3N2
|
81.7 Percentage of participants
Interval 77.4 to 85.4
|
44.9 Percentage of participants
Interval 39.8 to 50.0
|
|
Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
A/H1N1
|
77.2 Percentage of participants
Interval 72.7 to 81.3
|
57.9 Percentage of participants
Interval 52.9 to 62.9
|
|
Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
B/Yamagata
|
29.8 Percentage of participants
Interval 25.3 to 34.6
|
28.8 Percentage of participants
Interval 24.3 to 33.6
|
|
Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
B/Victoria
|
23.5 Percentage of participants
Interval 19.3 to 28.0
|
36.9 Percentage of participants
Interval 32.1 to 41.9
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks after vaccinationPopulation: As there was no participant from southern hemisphere aged 18-64 years, no data was collected for this outcome measure. Therefore, there was no analysis performed for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 4 weeks after vaccinationPopulation: Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Outcome measures
| Measure |
qIRV: 18-64 Years
n=391 Participants
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=390 Participants
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
4 weeks after vaccination: A/H3N2
|
98.2 Percentage of participants
Interval 96.3 to 99.3
|
89.8 Percentage of participants
Interval 86.3 to 92.6
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
Baseline: A/H3N2
|
61.3 Percentage of participants
Interval 56.2 to 66.2
|
58.3 Percentage of participants
Interval 53.1 to 63.3
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
Baseline: A/H1N1
|
27.9 Percentage of participants
Interval 23.5 to 32.7
|
28.5 Percentage of participants
Interval 24.0 to 33.2
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
4 weeks after vaccination: A/H1N1
|
85.6 Percentage of participants
Interval 81.8 to 89.0
|
77.9 Percentage of participants
Interval 73.5 to 82.0
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
Baseline: B/Yamagata
|
28.5 Percentage of participants
Interval 24.1 to 33.3
|
26.7 Percentage of participants
Interval 22.3 to 31.4
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
4 weeks after vaccination: B/Yamagata
|
69.4 Percentage of participants
Interval 64.6 to 74.0
|
61.9 Percentage of participants
Interval 56.9 to 66.8
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
Baseline: B/Victoria
|
38.1 Percentage of participants
Interval 33.3 to 43.2
|
34.6 Percentage of participants
Interval 29.9 to 39.6
|
|
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
4 weeks after vaccination: B/Victoria
|
69.3 Percentage of participants
Interval 64.5 to 73.9
|
73.8 Percentage of participants
Interval 69.2 to 78.1
|
Adverse Events
qIRV: 18-64 Years
Licensed QIV: 18-64 Years
qIRV: >=65 Years
Licensed QIV: >=65 Years
qIRV (>=18 Years)
Licensed QIV: >=18 Years
Serious adverse events
| Measure |
qIRV: 18-64 Years
n=9191 participants at risk
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=9197 participants at risk
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
qIRV: >=65 Years
n=13557 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
|
Licensed QIV: >=65 Years
n=13611 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
qIRV (>=18 Years)
n=22787 participants at risk
Participants aged \>=18 years were randomized to receive a single dose of qIRV dose level 1 (low) and dose level 2 (high) IM on Day 1.
|
Licensed QIV: >=18 Years
n=22808 participants at risk
Participants aged \>=18 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
4/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
4/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Blood and lymphatic system disorders
Monoclonal B-cell lymphocytosis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
2/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
6/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.07%
10/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
7/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.05%
12/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Angina pectoris
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Atrial fibrillation
|
0.02%
2/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.15%
21/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.11%
15/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.10%
23/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.07%
16/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Cardiac aneurysm
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
2/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.06%
8/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
8/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
5/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Cardiac failure
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
4/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.02%
2/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
2/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.07%
10/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.10%
13/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.05%
12/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.07%
15/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
4/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
5/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
4/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
6/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Cor pulmonale
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.07%
9/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.05%
7/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
9/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
7/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Dilated cardiomyopathy
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Mitral valve prolapse
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
3/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.06%
8/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.05%
7/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
8/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
10/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Palpitations
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
4/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Trifascicular block
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
4/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Ear and labyrinth disorders
Middle ear disorder
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Endocrine disorders
Cushing's syndrome
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Eye disorders
Glaucoma
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Eye disorders
Vision blurred
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Anogenital dysplasia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Ileal perforation
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
2/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
5/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Peptic ulcer perforation
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Retroperitoneal effusion
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
4/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
General disorders
Asthenia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
General disorders
Chest pain
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.07%
9/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
9/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
General disorders
Death
|
0.02%
2/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
6/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
8/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
General disorders
Multi-organ disorder
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
4/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
4/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
General disorders
Oedema peripheral
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
General disorders
Organ failure
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
General disorders
Vaccination site reaction
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
General disorders
Vascular stent stenosis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.02%
2/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
4/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
5/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
5/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Immune system disorders
Anaphylactic reaction
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Amoebic dysentery
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Appendicitis
|
0.04%
4/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
2/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
6/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Bacteraemia
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
COVID-19
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
4/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
4/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Cellulitis
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
3/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
5/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
6/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
6/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
9/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Cystitis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Diabetic foot infection
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Diverticulitis
|
0.02%
2/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
2/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
4/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
6/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
4/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Diverticulitis intestinal haemorrhagic
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Fungaemia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Gangrene
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Haemophilus bacteraemia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Infection
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Infective tenosynovitis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Influenza
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Kidney infection
|
0.02%
2/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Localised infection
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Meningitis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Pneumonia
|
0.08%
7/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.08%
7/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.18%
25/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.18%
25/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.14%
32/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.14%
32/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Post procedural sepsis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Post-acute COVID-19 syndrome
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Sepsis
|
0.02%
2/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
2/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.07%
9/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.06%
8/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.05%
11/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
10/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Septic arthritis staphylococcal
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Septic shock
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
6/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.05%
7/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
6/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
7/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Submandibular abscess
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
2/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.05%
7/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
7/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Viral infection
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Infections and infestations
Wound infection
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Craniofacial fracture
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Dislocation of vertebra
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Dural tear
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
5/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
5/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
4/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
4/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Gastrointestinal procedural complication
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
5/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
5/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Spinal cord injury cervical
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Vaginal cuff dehiscence
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Investigations
Blood glucose increased
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Investigations
Human rhinovirus test positive
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
6/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
6/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
5/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
5/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
4/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
4/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
2/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
4/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
4/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
6/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
4/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
7/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
5/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder adenocarcinoma
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer metastatic
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer recurrent
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatobiliary cancer
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage III
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to pleura
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic bronchial carcinoma
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic uterine cancer
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mueller's mixed tumour
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of the bladder
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ocular lymphoma
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.02%
2/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
4/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
5/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
6/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
5/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat cancer
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urinary tract neoplasm
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Axonal and demyelinating polyneuropathy
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Basal ganglia infarction
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Brain stem stroke
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.06%
8/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.07%
9/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
9/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
9/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Headache
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Idiopathic intracranial hypertension
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
4/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
4/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
4/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
4/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Migraine
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Myelin oligodendrocyte glycoprotein antibody-associated disease
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Ophthalmic migraine
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Seizure
|
0.02%
2/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
5/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Status epilepticus
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
4/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Syncope
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
3/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
4/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
4/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
6/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
6/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
5/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
7/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
5/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.02%
2/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
2/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Pregnancy, puerperium and perinatal conditions
Anembryonic gestation
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Product Issues
Device dislocation
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Product Issues
Device inappropriate shock delivery
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Product Issues
Device issue
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Product Issues
Device occlusion
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Psychiatric disorders
Alcohol abuse
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Psychiatric disorders
Anxiety
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Psychiatric disorders
Bipolar disorder
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Psychiatric disorders
Depression
|
0.02%
2/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
2/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Psychiatric disorders
Drug abuse
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Psychiatric disorders
Dysphemia
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Psychiatric disorders
Major depression
|
0.02%
2/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Psychiatric disorders
Mania
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Psychiatric disorders
Mental disorder
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Psychiatric disorders
Suicidal ideation
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.12%
16/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.05%
7/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.07%
17/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
8/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
4/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
4/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Renal and urinary disorders
Glomerulonephritis rapidly progressive
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Renal and urinary disorders
Nephrosclerosis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Renal and urinary disorders
Renal tubular injury
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
4/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
4/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Reproductive system and breast disorders
Ovarian mass
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
2/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.13%
17/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
6/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.08%
18/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
8/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma-chronic obstructive pulmonary disease overlap syndrome
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial disorder
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.02%
2/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
3/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.07%
10/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.09%
12/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.05%
12/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.07%
15/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mass
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haematoma
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
4/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
4/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
4/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
5/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis aspiration
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.05%
7/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.04%
5/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
7/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
5/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
3/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
3/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.02%
2/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
4/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.03%
6/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Social circumstances
Substance use
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Surgical and medical procedures
Hospitalisation
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Aortic dilatation
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Aortic embolus
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Aortic intramural haematoma
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Aortic thrombosis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Cyanosis
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Haematoma
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Hypertension
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Hypotension
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Intermittent claudication
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Internal haemorrhage
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Necrosis ischaemic
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Penetrating atherosclerotic ulcer
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
2/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Scalp haematoma
|
0.00%
0/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.01%
1/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Vascular disorders
Shock
|
0.01%
1/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
1/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.00%
0/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
Other adverse events
| Measure |
qIRV: 18-64 Years
n=9191 participants at risk
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
|
Licensed QIV: 18-64 Years
n=9197 participants at risk
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
qIRV: >=65 Years
n=13557 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
|
Licensed QIV: >=65 Years
n=13611 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
qIRV (>=18 Years)
n=22787 participants at risk
Participants aged \>=18 years were randomized to receive a single dose of qIRV dose level 1 (low) and dose level 2 (high) IM on Day 1.
|
Licensed QIV: >=18 Years
n=22808 participants at risk
Participants aged \>=18 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea (DIARRHEA)
|
3.9%
355/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
3.6%
332/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
2.0%
272/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
1.7%
237/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
2.8%
627/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
2.5%
569/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
General disorders
Chills (CHILLS)
|
8.0%
731/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
2.7%
249/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
4.3%
580/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.98%
133/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
5.8%
1311/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
1.7%
382/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
General disorders
Fatigue (FATIGUE)
|
17.2%
1579/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
11.4%
1046/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
12.0%
1624/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
6.0%
812/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
14.1%
3203/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
8.1%
1858/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
General disorders
Injection site erythema (REDNESS)
|
2.5%
230/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
1.1%
105/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
2.8%
376/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.70%
95/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
2.7%
606/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.88%
200/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
General disorders
Injection site pain
|
1.5%
142/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.72%
66/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
2.0%
274/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.54%
74/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
1.8%
416/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.61%
140/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
General disorders
Injection site pain (PAIN)
|
23.0%
2112/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
14.0%
1284/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
17.6%
2391/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
6.2%
840/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
19.8%
4503/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
9.3%
2124/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
General disorders
Injection site swelling (SWELLING)
|
2.8%
254/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
1.4%
129/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
2.8%
383/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.95%
129/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
2.8%
637/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
1.1%
258/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
General disorders
Pyrexia (FEVER)
|
1.8%
170/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.57%
52/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
1.5%
201/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.26%
36/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
1.6%
371/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
0.39%
88/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN)
|
5.4%
493/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
2.3%
208/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
3.0%
407/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
1.5%
201/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
3.9%
900/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
1.8%
409/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (MUSCLE PAIN)
|
10.0%
920/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
3.3%
307/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
5.3%
715/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
1.8%
251/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
7.2%
1635/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
2.4%
558/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
|
Nervous system disorders
Headache (HEADACHE)
|
13.9%
1273/9191 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
9.3%
853/9197 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
7.7%
1043/13557 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
4.0%
543/13611 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
10.2%
2316/22787 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
6.1%
1396/22808 • Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER