Trial Outcomes & Findings for A Study of V950 in People With Alzheimer Disease (V950-001 AM7) (NCT NCT00464334)
NCT ID: NCT00464334
Last Updated: 2015-09-25
Results Overview
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
86 participants
Primary outcome timeframe
Up to 4 years after first dose of vaccine
Results posted on
2015-09-25
Participant Flow
Participants were recruited from 51 sites in Europe, South America and the United States. The primary treatment period was from June 2007 to August 2010, with follow up through January 2012.
Participant milestones
| Measure |
Placebo to V950/IMX 0 mcg
Participants receive Placebo to V950/ISCOMATRIX™ (IMX) 0 mcg
|
Placebo to V950/IMX 16 mcg
Participants receive Placebo to V950/IMX 16 mcg
|
V950 0.5 mcg/IMX 0 mcg
Participants receive V950 0.5 mcg/IMX 0 mcg
|
V950 0.5 mcg/IMX 16 mcg
Participants receive V950 0.5 mcg/IMX 16 mcg
|
V950 0.5 mcg/IMX 47 mcg
Participants receive V950 0.5 mcg/IMX 47 mcg
|
V950 0.5 mcg/IMX 94 mcg
Participants receive V950 0.5 mcg/IMX 94 mcg
|
V950 5 mcg/IMX 0 mcg
Participants receive V950 5 mcg/IMX 0 mcg
|
V950 5 mcg/IMX 16 mcg
Participants receive V950 5 mcg/IMX 16 mcg
|
V950 5 mcg/IMX 47 mcg
Participants receive V950 5 mcg/IMX 47 mcg
|
V950 50 mcg/IMX 0 mcg
Participants receive V950 50 mcg/IMX 0 mcg
|
V950 50 mcg/IMX 16 mcg
Participants receive V950 50 mcg/IMX 16 mcg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
13
|
8
|
8
|
7
|
7
|
9
|
8
|
8
|
5
|
8
|
|
Overall Study
COMPLETED
|
4
|
5
|
3
|
4
|
3
|
3
|
6
|
7
|
2
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
8
|
5
|
4
|
4
|
4
|
3
|
1
|
6
|
1
|
4
|
Reasons for withdrawal
| Measure |
Placebo to V950/IMX 0 mcg
Participants receive Placebo to V950/ISCOMATRIX™ (IMX) 0 mcg
|
Placebo to V950/IMX 16 mcg
Participants receive Placebo to V950/IMX 16 mcg
|
V950 0.5 mcg/IMX 0 mcg
Participants receive V950 0.5 mcg/IMX 0 mcg
|
V950 0.5 mcg/IMX 16 mcg
Participants receive V950 0.5 mcg/IMX 16 mcg
|
V950 0.5 mcg/IMX 47 mcg
Participants receive V950 0.5 mcg/IMX 47 mcg
|
V950 0.5 mcg/IMX 94 mcg
Participants receive V950 0.5 mcg/IMX 94 mcg
|
V950 5 mcg/IMX 0 mcg
Participants receive V950 5 mcg/IMX 0 mcg
|
V950 5 mcg/IMX 16 mcg
Participants receive V950 5 mcg/IMX 16 mcg
|
V950 5 mcg/IMX 47 mcg
Participants receive V950 5 mcg/IMX 47 mcg
|
V950 50 mcg/IMX 0 mcg
Participants receive V950 50 mcg/IMX 0 mcg
|
V950 50 mcg/IMX 16 mcg
Participants receive V950 50 mcg/IMX 16 mcg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
2
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
2
|
|
Overall Study
Progressive Disease
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
7
|
4
|
2
|
2
|
2
|
2
|
1
|
3
|
0
|
0
|
Baseline Characteristics
A Study of V950 in People With Alzheimer Disease (V950-001 AM7)
Baseline characteristics by cohort
| Measure |
Placebo to V950/IMX 0 mcg
n=5 Participants
Participants receive Placebo to V950/IMX 0 mcg
|
Placebo to V950/IMX 16 mcg
n=13 Participants
Participants receive Placebo to V950/IMX 16 mcg
|
V950 0.5 mcg/IMX 0 mcg
n=8 Participants
Participants receive V950 0.5 mcg/IMX 0 mcg
|
V950 0.5 mcg/IMX 16 mcg
n=8 Participants
Participants receive V950 0.5 mcg/IMX 16 mcg
|
V950 0.5 mcg/IMX 47 mcg
n=7 Participants
Participants receive V950 0.5 mcg/IMX 47 mcg
|
V950 0.5 mcg/IMX 94 mcg
n=7 Participants
Participants receive V950 0.5 mcg/IMX 94 mcg
|
V950 5 mcg/IMX 0 mcg
n=9 Participants
Participants receive V950 5 mcg/IMX 0 mcg
|
V950 5 mcg/IMX 16 mcg
n=8 Participants
Participants receive V950 5 mcg/IMX 16 mcg
|
V950 5 mcg/IMX 47 mcg
n=8 Participants
Participants receive V950 5 mcg/IMX 47 mcg
|
V950 50 mcg/IMX 0 mcg
n=5 Participants
Participants receive V950 50 mcg/IMX 0 mcg
|
V950 50 mcg/IMX 16 mcg
n=8 Participants
Participants receive V950 50 mcg/IMX 16 mcg
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
73.6 years
STANDARD_DEVIATION 10.69 • n=93 Participants
|
70.7 years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
76.9 years
STANDARD_DEVIATION 4.39 • n=27 Participants
|
73.6 years
STANDARD_DEVIATION 8.07 • n=483 Participants
|
76.1 years
STANDARD_DEVIATION 8.01 • n=36 Participants
|
73.4 years
STANDARD_DEVIATION 10.89 • n=10 Participants
|
72.6 years
STANDARD_DEVIATION 9.26 • n=115 Participants
|
72.5 years
STANDARD_DEVIATION 10.10 • n=40 Participants
|
81.5 years
STANDARD_DEVIATION 5.48 • n=8 Participants
|
70.6 years
STANDARD_DEVIATION 8.38 • n=62 Participants
|
75.5 years
STANDARD_DEVIATION 10.04 • n=95 Participants
|
74.2 years
STANDARD_DEVIATION 8.85 • n=129 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
5 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=62 Participants
|
3 Participants
n=95 Participants
|
45 Participants
n=129 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
7 Participants
n=8 Participants
|
2 Participants
n=62 Participants
|
5 Participants
n=95 Participants
|
41 Participants
n=129 Participants
|
PRIMARY outcome
Timeframe: Up to 4 years after first dose of vaccinePopulation: Population consists of all participants who received at least one dose of vaccine.
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Outcome measures
| Measure |
Placebo to V950/ IMX 0 mcg
n=5 Participants
Participants receive Placebo to V950/IMX 0 mcg
|
Placebo to V950/ IMX 16 mcg
n=13 Participants
Participants receive Placebo to V950/IMX 16 mcg
|
V950 0.5 mcg / IMX 0 mcg
n=8 Participants
Participants receive V950 0.5 mcg/IMX 0 mcg
|
V950 0.5 mcg / IMX 16 mcg
n=8 Participants
Participants receive V950 0.5 mcg/IMX 16 mcg
|
V950 0.5 mcg / IMX 47 mcg
n=7 Participants
Participants receive V950 0.5 mcg/IMX 47 mcg
|
V950 0.5 mcg / IMX 94 mcg
n=7 Participants
Participants receive V950 0.5 mcg/IMX 94 mcg
|
V950 5 mcg / IMX 0 mcg
n=9 Participants
Participants receive V950 5 mcg/IMX 0 mcg
|
V950 5 mcg / IMX 16 mcg
n=8 Participants
Participants receive V950 5 mcg/IMX 16 mcg
|
V950 5 mcg / IMX 47 mcg
n=8 Participants
Participants receive V950 5 mcg/IMX 47 mcg
|
V950 50 mcg / IMX 0 mcg
n=5 Participants
Participants receive V950 50 mcg/IMX 0 mcg
|
V950 50 mcg / IMX 16 mcg
n=8 Participants
Participants receive V950 50 mcg/IMX 16 mcg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced at Least One Adverse Event
|
4 participants
|
11 participants
|
7 participants
|
8 participants
|
6 participants
|
7 participants
|
9 participants
|
8 participants
|
8 participants
|
5 participants
|
8 participants
|
PRIMARY outcome
Timeframe: Up to 6 months after first dose of vaccinePopulation: Population consists of all participants who received at least one dose of vaccine.
This is a measure of the number of participants who discontinued study drug because of an adverse event. An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Outcome measures
| Measure |
Placebo to V950/ IMX 0 mcg
n=5 Participants
Participants receive Placebo to V950/IMX 0 mcg
|
Placebo to V950/ IMX 16 mcg
n=13 Participants
Participants receive Placebo to V950/IMX 16 mcg
|
V950 0.5 mcg / IMX 0 mcg
n=8 Participants
Participants receive V950 0.5 mcg/IMX 0 mcg
|
V950 0.5 mcg / IMX 16 mcg
n=8 Participants
Participants receive V950 0.5 mcg/IMX 16 mcg
|
V950 0.5 mcg / IMX 47 mcg
n=7 Participants
Participants receive V950 0.5 mcg/IMX 47 mcg
|
V950 0.5 mcg / IMX 94 mcg
n=7 Participants
Participants receive V950 0.5 mcg/IMX 94 mcg
|
V950 5 mcg / IMX 0 mcg
n=9 Participants
Participants receive V950 5 mcg/IMX 0 mcg
|
V950 5 mcg / IMX 16 mcg
n=8 Participants
Participants receive V950 5 mcg/IMX 16 mcg
|
V950 5 mcg / IMX 47 mcg
n=8 Participants
Participants receive V950 5 mcg/IMX 47 mcg
|
V950 50 mcg / IMX 0 mcg
n=5 Participants
Participants receive V950 50 mcg/IMX 0 mcg
|
V950 50 mcg / IMX 16 mcg
n=8 Participants
Participants receive V950 50 mcg/IMX 16 mcg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
3 participants
|
1 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Month 7Population: Population consists of all participants who received three doses of vaccine and had no protocol violations. No participants in the V950 50 mcg/IMX 0 mcg group had data for the Month 7 evaluation.
The level of Aβ Peptide 1-40 specific antibodies was measured as the geometric mean titer (GMT) one month after the third dose (Month 7) of vaccine using an enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Placebo to V950/ IMX 0 mcg
n=4 Participants
Participants receive Placebo to V950/IMX 0 mcg
|
Placebo to V950/ IMX 16 mcg
n=4 Participants
Participants receive Placebo to V950/IMX 16 mcg
|
V950 0.5 mcg / IMX 0 mcg
n=8 Participants
Participants receive V950 0.5 mcg/IMX 0 mcg
|
V950 0.5 mcg / IMX 16 mcg
n=7 Participants
Participants receive V950 0.5 mcg/IMX 16 mcg
|
V950 0.5 mcg / IMX 47 mcg
n=1 Participants
Participants receive V950 0.5 mcg/IMX 47 mcg
|
V950 0.5 mcg / IMX 94 mcg
n=6 Participants
Participants receive V950 0.5 mcg/IMX 94 mcg
|
V950 5 mcg / IMX 0 mcg
n=9 Participants
Participants receive V950 5 mcg/IMX 0 mcg
|
V950 5 mcg / IMX 16 mcg
n=1 Participants
Participants receive V950 5 mcg/IMX 16 mcg
|
V950 5 mcg / IMX 47 mcg
n=6 Participants
Participants receive V950 5 mcg/IMX 47 mcg
|
V950 50 mcg / IMX 0 mcg
Participants receive V950 50 mcg/IMX 0 mcg
|
V950 50 mcg / IMX 16 mcg
n=5 Participants
Participants receive V950 50 mcg/IMX 16 mcg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7
|
363 ng/mL
Interval 161.0 to 729.0
|
542.08 ng/mL
Interval 310.16 to 818.02
|
855 ng/mL
Interval 575.0 to 1275.0
|
443 ng/mL
Interval 345.0 to 560.0
|
990 ng/mL
Interval 990.0 to 990.0
|
2208.02 ng/mL
Interval 628.53 to 12105.0
|
725 ng/mL
Interval 378.0 to 1385.0
|
3835 ng/mL
Interval 3835.0 to 3835.0
|
1277.38 ng/mL
Interval 604.83 to 2453.4
|
—
|
935.55 ng/mL
Interval 447.14 to 1728.0
|
PRIMARY outcome
Timeframe: Baseline and Month 7Population: Population consists of all participants who received three doses of vaccine and had no protocol violations. No participants in the V950 50 mcg/IMX 0 mcg group had data for the Month 7 evaluation.
The Aβ Peptide 1-40 specific immunogenicity of 3-dose regimen of V950 was measured one month after the third dose (Month 7) of vaccine by the GMT fold change of Aβ 1-40 specific antibodies compared to Baseline (Month 0) using ELISA.
Outcome measures
| Measure |
Placebo to V950/ IMX 0 mcg
n=4 Participants
Participants receive Placebo to V950/IMX 0 mcg
|
Placebo to V950/ IMX 16 mcg
n=4 Participants
Participants receive Placebo to V950/IMX 16 mcg
|
V950 0.5 mcg / IMX 0 mcg
n=8 Participants
Participants receive V950 0.5 mcg/IMX 0 mcg
|
V950 0.5 mcg / IMX 16 mcg
n=7 Participants
Participants receive V950 0.5 mcg/IMX 16 mcg
|
V950 0.5 mcg / IMX 47 mcg
n=1 Participants
Participants receive V950 0.5 mcg/IMX 47 mcg
|
V950 0.5 mcg / IMX 94 mcg
n=6 Participants
Participants receive V950 0.5 mcg/IMX 94 mcg
|
V950 5 mcg / IMX 0 mcg
n=9 Participants
Participants receive V950 5 mcg/IMX 0 mcg
|
V950 5 mcg / IMX 16 mcg
n=1 Participants
Participants receive V950 5 mcg/IMX 16 mcg
|
V950 5 mcg / IMX 47 mcg
n=5 Participants
Participants receive V950 5 mcg/IMX 47 mcg
|
V950 50 mcg / IMX 0 mcg
Participants receive V950 50 mcg/IMX 0 mcg
|
V950 50 mcg / IMX 16 mcg
n=5 Participants
Participants receive V950 50 mcg/IMX 16 mcg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies
|
0.89 fold change
Interval 0.7 to 1.16
|
0.76 fold change
Interval 0.49 to 1.06
|
0.98 fold change
Interval 0.79 to 1.17
|
1.02 fold change
Interval 0.82 to 1.27
|
0.15 fold change
Interval 0.15 to 0.15
|
2.68 fold change
Interval 1.03 to 8.66
|
0.74 fold change
Interval 0.18 to 1.8
|
2.27 fold change
Interval 2.27 to 2.27
|
1.38 fold change
Interval 0.84 to 2.78
|
—
|
1.84 fold change
Interval 1.29 to 2.67
|
Adverse Events
Placebo to V950/ IMX 0 mcg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo to V950/ IMX 16 mcg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
V950 0.5 mcg / IMX 0 mcg
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
V950 0.5 mcg / IMX 16 mcg
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
V950 0.5 mcg / IMX 47 mcg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
V950 0.5 mcg / IMX 94 mcg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
V950 5 mcg / IMX 0 mcg
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
V950 5 mcg / IMX 16 mcg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
V950 5 mcg / IMX 47 mcg
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
V950 50 mcg / IMX 0 mcg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
V950 50 mcg / IMX 16 mcg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo to V950/ IMX 0 mcg
n=5 participants at risk
Participants receive Placebo to V950/IMX 0 mcg
|
Placebo to V950/ IMX 16 mcg
n=13 participants at risk
Participants receive Placebo to V950/IMX 16 mcg
|
V950 0.5 mcg / IMX 0 mcg
n=8 participants at risk
Participants receive V950 0.5 mcg/IMX 0 mcg
|
V950 0.5 mcg / IMX 16 mcg
n=8 participants at risk
Participants receive V950 0.5 mcg/IMX 16 mcg
|
V950 0.5 mcg / IMX 47 mcg
n=7 participants at risk
Participants receive V950 0.5 mcg/IMX 47 mcg
|
V950 0.5 mcg / IMX 94 mcg
n=7 participants at risk
Participants receive V950 0.5 mcg/IMX 94 mcg
|
V950 5 mcg / IMX 0 mcg
n=9 participants at risk
Participants receive V950 5 mcg/IMX 0 mcg
|
V950 5 mcg / IMX 16 mcg
n=8 participants at risk
Participants receive V950 5 mcg/IMX 16 mcg
|
V950 5 mcg / IMX 47 mcg
n=8 participants at risk
Participants receive V950 5 mcg/IMX 47 mcg
|
V950 50 mcg / IMX 0 mcg
n=5 participants at risk
Participants receive V950 50 mcg/IMX 0 mcg
|
V950 50 mcg / IMX 16 mcg
n=8 participants at risk
Participants receive V950 50 mcg/IMX 16 mcg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
25.0%
2/8 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
General disorders
Chest pain
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Injury, poisoning and procedural complications
Contusion
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 3 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Vascular disorders
Orthostatic hypotension
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
Other adverse events
| Measure |
Placebo to V950/ IMX 0 mcg
n=5 participants at risk
Participants receive Placebo to V950/IMX 0 mcg
|
Placebo to V950/ IMX 16 mcg
n=13 participants at risk
Participants receive Placebo to V950/IMX 16 mcg
|
V950 0.5 mcg / IMX 0 mcg
n=8 participants at risk
Participants receive V950 0.5 mcg/IMX 0 mcg
|
V950 0.5 mcg / IMX 16 mcg
n=8 participants at risk
Participants receive V950 0.5 mcg/IMX 16 mcg
|
V950 0.5 mcg / IMX 47 mcg
n=7 participants at risk
Participants receive V950 0.5 mcg/IMX 47 mcg
|
V950 0.5 mcg / IMX 94 mcg
n=7 participants at risk
Participants receive V950 0.5 mcg/IMX 94 mcg
|
V950 5 mcg / IMX 0 mcg
n=9 participants at risk
Participants receive V950 5 mcg/IMX 0 mcg
|
V950 5 mcg / IMX 16 mcg
n=8 participants at risk
Participants receive V950 5 mcg/IMX 16 mcg
|
V950 5 mcg / IMX 47 mcg
n=8 participants at risk
Participants receive V950 5 mcg/IMX 47 mcg
|
V950 50 mcg / IMX 0 mcg
n=5 participants at risk
Participants receive V950 50 mcg/IMX 0 mcg
|
V950 50 mcg / IMX 16 mcg
n=8 participants at risk
Participants receive V950 50 mcg/IMX 16 mcg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Infections and infestations
Wound infection
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Gastrointestinal disorders
Gingival bleeding
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Gastrointestinal disorders
Gingivitis
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
25.0%
2/8 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Eye disorders
Glaucoma
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Eye disorders
Visual impairment
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
23.1%
3/13 • Number of events 3 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
28.6%
2/7 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Gastrointestinal disorders
Dysphagia
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
28.6%
2/7 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
General disorders
Asthenia
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
General disorders
Fatigue
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
25.0%
2/8 • Number of events 3 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
General disorders
Feeling cold
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
General disorders
Gait disturbance
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
General disorders
Influenza like illness
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
General disorders
Injection site discomfort
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
General disorders
Injection site erythema
|
20.0%
1/5 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
15.4%
2/13 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
28.6%
2/7 • Number of events 3 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
42.9%
3/7 • Number of events 3 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
25.0%
2/8 • Number of events 4 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
37.5%
3/8 • Number of events 5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
40.0%
2/5 • Number of events 4 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
75.0%
6/8 • Number of events 11 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
General disorders
Injection site haematoma
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
General disorders
Injection site hypersensitivity
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
General disorders
Injection site mass
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
General disorders
Injection site pain
|
20.0%
1/5 • Number of events 3 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
23.1%
3/13 • Number of events 4 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
50.0%
4/8 • Number of events 9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
100.0%
7/7 • Number of events 10 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
44.4%
4/9 • Number of events 6 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
37.5%
3/8 • Number of events 4 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
50.0%
4/8 • Number of events 9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
100.0%
5/5 • Number of events 13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
62.5%
5/8 • Number of events 13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
General disorders
Injection site pruritus
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
General disorders
Injection site rash
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
General disorders
Injection site swelling
|
20.0%
1/5 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
15.4%
2/13 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
37.5%
3/8 • Number of events 4 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
28.6%
2/7 • Number of events 3 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
28.6%
2/7 • Number of events 3 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
25.0%
2/8 • Number of events 3 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
37.5%
3/8 • Number of events 6 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
60.0%
3/5 • Number of events 6 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
62.5%
5/8 • Number of events 5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
General disorders
Malaise
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
General disorders
Oedema peripheral
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
General disorders
Pain
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
37.5%
3/8 • Number of events 3 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Infections and infestations
Cystitis
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Infections and infestations
Localised infection
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Infections and infestations
Prostate infection
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Infections and infestations
Sinusitis
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
25.0%
2/8 • Number of events 4 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
28.6%
2/7 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Injury, poisoning and procedural complications
Documented hypersensitivity to administered drug
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Injury, poisoning and procedural complications
Fall
|
40.0%
2/5 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Injury, poisoning and procedural complications
Laceration
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Investigations
Blood amylase increased
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Investigations
CSF glucose increased
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Investigations
CSF protein increased
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Investigations
Neurological examination abnormal
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Investigations
Temperature perception test decreased
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Investigations
Weight decreased
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
25.0%
2/8 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Metabolism and nutrition disorders
Salt craving
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
25.0%
2/8 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
15.4%
2/13 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Nervous system disorders
Cerebral microhaemorrhage
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Nervous system disorders
Decreased vibratory sense
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 3 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Nervous system disorders
Glabellar reflex abnormal
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
42.9%
3/7 • Number of events 6 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
33.3%
3/9 • Number of events 3 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
60.0%
3/5 • Number of events 5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Nervous system disorders
Hyporeflexia
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Nervous system disorders
Intention tremor
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
25.0%
2/8 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Nervous system disorders
Tremor
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Psychiatric disorders
Agitation
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
15.4%
2/13 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
25.0%
2/8 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Psychiatric disorders
Daydreaming
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Psychiatric disorders
Depression
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
25.0%
2/8 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Psychiatric disorders
Mental status changes
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
40.0%
2/5 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 3 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
20.0%
1/5 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Skin and subcutaneous tissue disorders
Hair disorder
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
20.0%
1/5 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
11.1%
1/9 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Vascular disorders
Haematoma
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/13 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
12.5%
1/8 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Vascular disorders
Hot flush
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/9 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
7.7%
1/13 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
14.3%
1/7 • Number of events 1 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/7 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
22.2%
2/9 • Number of events 2 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/5 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
0.00%
0/8 • Up to 4 years after first dose of vaccine
The Safety Population consisted of all participants who received at least one dose of vaccine.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER