Trial Outcomes & Findings for Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age (NCT NCT03276962)
NCT ID: NCT03276962
Last Updated: 2024-05-21
Results Overview
The primary case definition is: Plasmodium (P.) falciparum asexual parasitemia greater than (\>)5000 parasites/microliters (μl) and presence of fever (axillary temperature greater than or equal to \[≥\]37.5°C) at the time of presentation and occurring in a child who is unwell and brought for treatment to a healthcare facility. The incidence is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T). The objective of this endpoint was to demonstrate the superiority of a Fx012-14-mFxD Group compared to a standard schedule of RTS,S/AS01E with three full doses (R012-20+R012-14 Group) in terms of vaccine efficacy. This analysis was reported for the R012-20+R012-14 Group (Pooled group) because the interventional strategy (1st dose at Month 0, 2nd dose at Month 1, 3rd dose at Month 2) was the same for both the R012-20 group and the R012-14 group until Month 14.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1500 participants
Primary outcome timeframe
From Month 2.5 to Month 14
Results posted on
2024-05-21
Participant Flow
As pre-specified in statistical analysis plan, data reported in Participant Flow, Baseline Characteristics and Adverse Events were presented for individual groups (R012-20 Group, R012-14-mD Group, R012-14-mD Group, Fx017-mFxD Group and Control Group).
As pre-specified in protocol, efficacy outcome measures corresponding to clinical malaria (primary case definition) and Plasmodium (P.) falciparum infection, presented data for R012-20+R012-14 Group (Pooled group) because the interventional strategy (1st dose at Month 0, 2nd dose at Month 1, 3rd dose at Month 2) was the same for both the R012-20 group and the R012-14 group until Month 14.
Participant milestones
| Measure |
R012-20 Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
|
R012-14-mD Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
|
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
298
|
294
|
304
|
311
|
293
|
|
Overall Study
COMPLETED
|
229
|
232
|
242
|
247
|
237
|
|
Overall Study
NOT COMPLETED
|
69
|
62
|
62
|
64
|
56
|
Reasons for withdrawal
| Measure |
R012-20 Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
|
R012-14-mD Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
|
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
|---|---|---|---|---|---|
|
Overall Study
Serious Adverse Event And/Or Pimd
|
2
|
1
|
0
|
4
|
1
|
|
Overall Study
Protocol Deviation
|
2
|
0
|
1
|
2
|
1
|
|
Overall Study
Consent Withdrawal, Not Due To An Adverse Event/A Serious Adverse Event
|
29
|
21
|
13
|
21
|
16
|
|
Overall Study
Migrated / Moved From The Study Area
|
26
|
28
|
44
|
29
|
27
|
|
Overall Study
Lost to Follow-up
|
10
|
10
|
4
|
6
|
10
|
|
Overall Study
Other
|
0
|
2
|
0
|
2
|
1
|
Baseline Characteristics
Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age
Baseline characteristics by cohort
| Measure |
R012-20 Group
n=298 Participants
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
|
R012-14-mD Group
n=294 Participants
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
|
Fx012-14-mFxD Group
n=304 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
n=311 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
n=293 Participants
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
Total
n=1500 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
10.2 Months
STANDARD_DEVIATION 3.9 • n=5 Participants
|
10.3 Months
STANDARD_DEVIATION 3.8 • n=7 Participants
|
10.5 Months
STANDARD_DEVIATION 4.0 • n=5 Participants
|
10.2 Months
STANDARD_DEVIATION 3.8 • n=4 Participants
|
10.5 Months
STANDARD_DEVIATION 3.9 • n=21 Participants
|
10.3 Months
STANDARD_DEVIATION 3.9 • n=10 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
163 Participants
n=4 Participants
|
152 Participants
n=21 Participants
|
761 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
179 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
148 Participants
n=4 Participants
|
141 Participants
n=21 Participants
|
739 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black Or African American
|
298 Participants
n=5 Participants
|
294 Participants
n=7 Participants
|
304 Participants
n=5 Participants
|
311 Participants
n=4 Participants
|
293 Participants
n=21 Participants
|
1500 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: From Month 2.5 to Month 14Population: This analysis was performed on Per Protocol Set (PPS) for efficacy, which included all participants from Exposed Set (ES) who fulfilled eligibility criteria and received all interventions as per study plan, within the protocol specified intervals that contribute to the time at risk in the follow-up period starting Month 2.5 to Month 14. As pre-specified in the analysis plan, the analysis of this outcome measure was reported for the R012-20+R012-14 Group and the Fx012-14-mFxD Group.
The primary case definition is: Plasmodium (P.) falciparum asexual parasitemia greater than (\>)5000 parasites/microliters (μl) and presence of fever (axillary temperature greater than or equal to \[≥\]37.5°C) at the time of presentation and occurring in a child who is unwell and brought for treatment to a healthcare facility. The incidence is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T). The objective of this endpoint was to demonstrate the superiority of a Fx012-14-mFxD Group compared to a standard schedule of RTS,S/AS01E with three full doses (R012-20+R012-14 Group) in terms of vaccine efficacy. This analysis was reported for the R012-20+R012-14 Group (Pooled group) because the interventional strategy (1st dose at Month 0, 2nd dose at Month 1, 3rd dose at Month 2) was the same for both the R012-20 group and the R012-14 group until Month 14.
Outcome measures
| Measure |
Fx012-14-mFxD Group
n=271 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
R012-20 + R012-14 Group
n=523 Participants
Participants received full doses of RTS,S/AS01E at Month 0, Month 1, Month 2 and a full dose at Month 14, Month 20, Month 26, Month 38.
|
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
|---|---|---|---|---|---|
|
Incidence of Clinical Malaria Meeting the Primary Case Definition
|
0.45 events per person-year
|
0.36 events per person-year
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Month 0 to Month 50Population: The analysis was performed on ES which included all participants who received at least one dose of study vaccine. As per statistical analysis plan, the analysis of this outcome measure was reported only for the Fx012-14-mFxD Group and the R012-20 Group since the objective of this endpoint was to assess the vaccine efficacy in terms of incident rate against Fx012-14-mFxD Group versus R012-20 Group.
The primary case definition is P. falciparum asexual parasitemia \> 5000 μl and presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation and occurring in a child who is unwell and brought for treatment to a healthcare facility. The secondary case definition is P. falciparum asexual parasitemia \> 0 and presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who is unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for primary and secondary case definition is expressed as n/T, representing the n reported over the risk period, which was counted in days and expressed as T.
Outcome measures
| Measure |
Fx012-14-mFxD Group
n=304 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
R012-20 + R012-14 Group
n=298 Participants
Participants received full doses of RTS,S/AS01E at Month 0, Month 1, Month 2 and a full dose at Month 14, Month 20, Month 26, Month 38.
|
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
|---|---|---|---|---|---|
|
Incidence of Clinical Malaria Meeting the Primary and Secondary Case Definitions of the Fx012-14-mFxD Group Versus the R012-20 Group
Primary case definition
|
0.69 events per person-year
|
0.86 events per person-year
|
—
|
—
|
—
|
|
Incidence of Clinical Malaria Meeting the Primary and Secondary Case Definitions of the Fx012-14-mFxD Group Versus the R012-20 Group
Secondary case definition
|
1.18 events per person-year
|
1.62 events per person-year
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Month 0 to Month 50Population: The analysis was performed on ES which included all participants who received at least one dose of study vaccine. As per statistical analysis plan, the analysis of this outcome measure was reported only for the Fx012-14-mFxD Group and the R012-14-mD Group since the objective of this endpoint was to assess the vaccine efficacy in terms of incident rate against Fx012-14-mFxD Group versus R012-14-mD Group..
The primary case definition is P. falciparum asexual parasitemia \> 5000 μl and presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation and occurring in a child who is unwell and brought for treatment to a healthcare facility. The secondary case definition is P. falciparum asexual parasitemia \> 0 and presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who is unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for primary and secondary case definition is expressed as n/T, representing the n reported over the risk period, which was counted in days and expressed as T.
Outcome measures
| Measure |
Fx012-14-mFxD Group
n=304 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
R012-20 + R012-14 Group
n=294 Participants
Participants received full doses of RTS,S/AS01E at Month 0, Month 1, Month 2 and a full dose at Month 14, Month 20, Month 26, Month 38.
|
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
|---|---|---|---|---|---|
|
Incidence of Clinical Malaria Meeting the Primary and Secondary Case Definitions of the Fx012-14-mFxD Group Versus the R012-14-mD Group
Primary case definition
|
0.69 events per person-year
|
0.67 events per person-year
|
—
|
—
|
—
|
|
Incidence of Clinical Malaria Meeting the Primary and Secondary Case Definitions of the Fx012-14-mFxD Group Versus the R012-14-mD Group
Secondary case definition
|
1.18 events per person-year
|
1.22 events per person-year
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Monthly from Month 0 to Month 20 and every 3 months thereafter until Study End (Month 50)Population: The analysis was performed on ES which included all participants who received at least one dose of study vaccine and for whom data were assessed during specific timepoints.
Prevalence of P. falciparum infections of each RTS,S/AS01E schedule at cross-sectional visits. As specified in the statistical analysis plan, a graphical presentation of the prevalence over time was analyzed for this outcome measure and only the percentage values were reported to depict the prevalence of P. falciparum infections.
Outcome measures
| Measure |
Fx012-14-mFxD Group
n=298 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
R012-20 + R012-14 Group
n=294 Participants
Participants received full doses of RTS,S/AS01E at Month 0, Month 1, Month 2 and a full dose at Month 14, Month 20, Month 26, Month 38.
|
Fx012-14-mFxD Group
n=304 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
n=311 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
n=293 Participants
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
|---|---|---|---|---|---|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 0
|
10.1 Percentage of participants
|
6.1 Percentage of participants
|
4.6 Percentage of participants
|
5.1 Percentage of participants
|
7.2 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 1
|
3.8 Percentage of participants
|
5.9 Percentage of participants
|
3.1 Percentage of participants
|
5.7 Percentage of participants
|
5.7 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 2
|
4.3 Percentage of participants
|
4.6 Percentage of participants
|
2.8 Percentage of participants
|
5.5 Percentage of participants
|
3.9 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 3
|
3.0 Percentage of participants
|
4.1 Percentage of participants
|
3.2 Percentage of participants
|
6.5 Percentage of participants
|
5.4 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 4
|
3.9 Percentage of participants
|
4.7 Percentage of participants
|
2.3 Percentage of participants
|
4.9 Percentage of participants
|
5.6 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 5
|
3.9 Percentage of participants
|
3.6 Percentage of participants
|
1.9 Percentage of participants
|
4.7 Percentage of participants
|
8.5 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 6
|
4.8 Percentage of participants
|
4.4 Percentage of participants
|
3.0 Percentage of participants
|
6.2 Percentage of participants
|
7.2 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 7
|
6.0 Percentage of participants
|
7.7 Percentage of participants
|
6.5 Percentage of participants
|
5.3 Percentage of participants
|
4.8 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 8
|
4.0 Percentage of participants
|
7.2 Percentage of participants
|
5.0 Percentage of participants
|
4.4 Percentage of participants
|
9.4 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 9
|
6.7 Percentage of participants
|
6.6 Percentage of participants
|
6.8 Percentage of participants
|
7.1 Percentage of participants
|
9.7 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 10
|
6.0 Percentage of participants
|
5.3 Percentage of participants
|
7.4 Percentage of participants
|
6.7 Percentage of participants
|
12.7 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 11
|
8.4 Percentage of participants
|
5.7 Percentage of participants
|
6.9 Percentage of participants
|
7.8 Percentage of participants
|
12.5 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 12
|
9.7 Percentage of participants
|
6.5 Percentage of participants
|
6.9 Percentage of participants
|
6.6 Percentage of participants
|
13.1 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 13
|
7.3 Percentage of participants
|
6.9 Percentage of participants
|
7.7 Percentage of participants
|
9.7 Percentage of participants
|
13.5 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 14
|
12.6 Percentage of participants
|
2.0 Percentage of participants
|
5.3 Percentage of participants
|
7.1 Percentage of participants
|
12.9 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 15
|
8.3 Percentage of participants
|
3.7 Percentage of participants
|
5.1 Percentage of participants
|
6.4 Percentage of participants
|
9.0 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 16
|
7.9 Percentage of participants
|
6.7 Percentage of participants
|
6.8 Percentage of participants
|
5.7 Percentage of participants
|
6.7 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 17
|
10.8 Percentage of participants
|
9.8 Percentage of participants
|
7.0 Percentage of participants
|
5.7 Percentage of participants
|
11.7 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 18
|
9.3 Percentage of participants
|
9.9 Percentage of participants
|
7.1 Percentage of participants
|
6.5 Percentage of participants
|
12.2 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 19
|
6.8 Percentage of participants
|
7.9 Percentage of participants
|
8.8 Percentage of participants
|
9.7 Percentage of participants
|
10.1 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 20
|
7.0 Percentage of participants
|
8.3 Percentage of participants
|
8.1 Percentage of participants
|
3.4 Percentage of participants
|
7.5 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 23
|
11.3 Percentage of participants
|
7.3 Percentage of participants
|
11.2 Percentage of participants
|
7.5 Percentage of participants
|
10.7 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 26
|
12.2 Percentage of participants
|
2.8 Percentage of participants
|
6.0 Percentage of participants
|
9.5 Percentage of participants
|
10.9 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 29
|
10.6 Percentage of participants
|
6.9 Percentage of participants
|
9.2 Percentage of participants
|
8.7 Percentage of participants
|
13.4 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 32
|
10.5 Percentage of participants
|
7.9 Percentage of participants
|
7.9 Percentage of participants
|
5.8 Percentage of participants
|
10.6 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 35
|
10.9 Percentage of participants
|
11.0 Percentage of participants
|
10.1 Percentage of participants
|
10.4 Percentage of participants
|
13.7 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 38
|
11.5 Percentage of participants
|
6.5 Percentage of participants
|
7.3 Percentage of participants
|
8.4 Percentage of participants
|
17.0 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 41
|
5.8 Percentage of participants
|
7.5 Percentage of participants
|
6.8 Percentage of participants
|
6.5 Percentage of participants
|
11.0 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 44
|
12.3 Percentage of participants
|
10.2 Percentage of participants
|
9.8 Percentage of participants
|
8.7 Percentage of participants
|
11.9 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 50
|
13.1 Percentage of participants
|
10.8 Percentage of participants
|
13.6 Percentage of participants
|
12.6 Percentage of participants
|
13.5 Percentage of participants
|
|
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Month 47
|
13.8 Percentage of participants
|
5.7 Percentage of participants
|
8.9 Percentage of participants
|
8.3 Percentage of participants
|
16.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Month 0 to Month 14Population: The analysis was performed on ES which included all participants who received at least one dose of study vaccine and for whom data were collected from Month 0 to Month 14. As pre-specified in the analysis plan, the analysis of the outcome measure was reported for the R012-20+R012-14 Group (Pooled group) because the interventional strategy (1st dose at Month 0, 2nd dose at Month 1 and 3rd dose at Month 2) was the same for both the R012-20 group and the R012-14 group until Month 14.
The incidence of P. falciparum infections is expressed as n/T, representing the n reported over the risk period, which was counted in days and expressed as T. Assessment of vaccine efficacy (VE) against first or only episodes of incident P. falciparum infections defined by positive blood slide over the entire study period (Month 0 to Month 50) was not done after the Month 21 Interim analysis since it was assumed that almost all children would have already contracted malaria at least once.
Outcome measures
| Measure |
Fx012-14-mFxD Group
n=543 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
R012-20 + R012-14 Group
n=290 Participants
Participants received full doses of RTS,S/AS01E at Month 0, Month 1, Month 2 and a full dose at Month 14, Month 20, Month 26, Month 38.
|
Fx012-14-mFxD Group
n=295 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
n=272 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
|---|---|---|---|---|---|
|
Incidence of P. Falciparum Infections Defined by Positive Blood Slide
|
0.50 events per person-year
|
0.60 events per person-year
|
0.59 events per person-year
|
0.80 events per person-year
|
—
|
SECONDARY outcome
Timeframe: Before Dose 1, one month post-Dose 2, before and one month post-Dose 3, before and one month after Dose 4, before and one month after each yearly dose and at Study End (Month 50)Population: The analysis was performed on immunosubset which included all participants who complied with protocol defined procedures and for whom immunogenicity results were available for the specified time point and specific assay.
A seropositive participant is defined as a participant with antibody concentrations ≥ 0.5 ELISA units per milliliter (EU/mL).
Outcome measures
| Measure |
Fx012-14-mFxD Group
n=45 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
R012-20 + R012-14 Group
n=49 Participants
Participants received full doses of RTS,S/AS01E at Month 0, Month 1, Month 2 and a full dose at Month 14, Month 20, Month 26, Month 38.
|
Fx012-14-mFxD Group
n=45 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
n=49 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
n=48 Participants
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
|---|---|---|---|---|---|
|
Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies
Before Dose 1, Pre-Vaccination (Day 1)
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies
Post Dose 2 (Month 2)
|
43 Participants
|
48 Participants
|
42 Participants
|
47 Participants
|
4 Participants
|
|
Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies
Post Dose 3 (Month 3)
|
36 Participants
|
44 Participants
|
40 Participants
|
—
|
2 Participants
|
|
Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies
Pre-Dose 3 (Month 7)
|
—
|
—
|
—
|
44 Participants
|
—
|
|
Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies
Post Dose 3 (Month 8)
|
—
|
—
|
—
|
43 Participants
|
—
|
|
Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies
Pre-Dose 4 (Month 14)
|
—
|
41 Participants
|
40 Participants
|
—
|
—
|
|
Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies
Post Dose 4 (Month 15)
|
—
|
37 Participants
|
38 Participants
|
—
|
—
|
|
Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies
Pre-Dose 4 (Month 20)
|
37 Participants
|
—
|
—
|
42 Participants
|
2 Participants
|
|
Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies
Post Dose 4 (Month 21)
|
35 Participants
|
—
|
—
|
39 Participants
|
—
|
|
Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies
Pre-Dose 5 (Month 26)
|
—
|
37 Participants
|
34 Participants
|
—
|
—
|
|
Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies
Post Dose 5 (Month 27)
|
—
|
30 Participants
|
26 Participants
|
—
|
—
|
|
Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies
Pre-Dose 5 (Month 32)
|
—
|
—
|
—
|
37 Participants
|
—
|
|
Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies
Post Dose 5 (Month 33)
|
—
|
—
|
—
|
32 Participants
|
—
|
|
Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies
Pre-Dose 6 (Month 38)
|
—
|
34 Participants
|
31 Participants
|
—
|
—
|
|
Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies
Post Dose 6 (Month 39)
|
—
|
33 Participants
|
28 Participants
|
—
|
—
|
|
Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies
End of Study (Month 50)
|
30 Participants
|
34 Participants
|
29 Participants
|
25 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Before Dose 1, one month post-Dose 2, before and one month post-Dose 3, before and one month after Dose 4, before and one month after each yearly dose and at Study End (Month 50)Population: The analysis was performed on the immunosubset which included all participants who complied with protocol defined procedures and for whom immunogenicity results were available for the specified time point and specific assay.
A seropositive participant is defined as a participant with antibody concentrations ≥ 10 milli-international units per milliliter (mIU/mL).
Outcome measures
| Measure |
Fx012-14-mFxD Group
n=45 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
R012-20 + R012-14 Group
n=49 Participants
Participants received full doses of RTS,S/AS01E at Month 0, Month 1, Month 2 and a full dose at Month 14, Month 20, Month 26, Month 38.
|
Fx012-14-mFxD Group
n=44 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
n=48 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
n=48 Participants
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
|---|---|---|---|---|---|
|
Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies
Before Dose 1, Pre-Vaccination (Day 1)
|
42 Participants
|
48 Participants
|
39 Participants
|
40 Participants
|
43 Participants
|
|
Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies
Post Dose 2 (Month 2)
|
43 Participants
|
48 Participants
|
41 Participants
|
48 Participants
|
42 Participants
|
|
Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies
Post Dose 3 (Month 3)
|
35 Participants
|
44 Participants
|
40 Participants
|
—
|
39 Participants
|
|
Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies
Pre-Dose 3 (Month 7)
|
—
|
—
|
—
|
44 Participants
|
—
|
|
Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies
Post Dose 3 (Month 8)
|
—
|
—
|
—
|
43 Participants
|
—
|
|
Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies
Pre-Dose 4 (Month 14)
|
—
|
41 Participants
|
40 Participants
|
—
|
—
|
|
Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies
Post Dose 4 (Month 15)
|
—
|
37 Participants
|
37 Participants
|
—
|
—
|
|
Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies
Pre-Dose 4 (Month 20)
|
37 Participants
|
—
|
—
|
42 Participants
|
30 Participants
|
|
Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies
Post Dose 4 (Month 21)
|
33 Participants
|
—
|
—
|
38 Participants
|
—
|
|
Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies
Pre-Dose 5 (Month 26)
|
—
|
38 Participants
|
34 Participants
|
—
|
—
|
|
Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies
Post Dose 5 (Month 27)
|
—
|
30 Participants
|
26 Participants
|
—
|
—
|
|
Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies
Pre-Dose 5 (Month 32)
|
—
|
—
|
—
|
37 Participants
|
—
|
|
Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies
Post Dose 5 (Month 33)
|
—
|
—
|
—
|
32 Participants
|
—
|
|
Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies
Pre-Dose 6 (Month 38)
|
—
|
34 Participants
|
31 Participants
|
—
|
—
|
|
Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies
Post Dose 6 (Month 39)
|
—
|
33 Participants
|
28 Participants
|
—
|
—
|
|
Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies
End of Study (Month 50)
|
30 Participants
|
34 Participants
|
28 Participants
|
25 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Before Dose 1, one month post-Dose 2, before and one month post-Dose 3, before and one month after Dose 4, before and one month after each yearly dose and at Study End (Month 50)Population: The analysis was performed on the immunosubset which included all participants who complied with protocol defined procedures and for whom immunogenicity results were available for the specified time point and specific assay.
The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as EU/mL.
Outcome measures
| Measure |
Fx012-14-mFxD Group
n=45 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
R012-20 + R012-14 Group
n=49 Participants
Participants received full doses of RTS,S/AS01E at Month 0, Month 1, Month 2 and a full dose at Month 14, Month 20, Month 26, Month 38.
|
Fx012-14-mFxD Group
n=45 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
n=49 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
n=48 Participants
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
|---|---|---|---|---|---|
|
Antibody Concentrations for Anti-CS
Before Dose 1, Pre-Vaccination (Day 1)
|
1.0 EU/mL
Interval 0.9 to 1.0
|
1.0 EU/mL
Interval 0.9 to 1.0
|
1.0 EU/mL
Interval 1.0 to 1.0
|
1.0 EU/mL
Interval 0.9 to 1.0
|
1.0 EU/mL
Interval 0.9 to 1.0
|
|
Antibody Concentrations for Anti-CS
Post Dose 2 (Month 2)
|
359.9 EU/mL
Interval 284.3 to 455.5
|
320.0 EU/mL
Interval 248.2 to 412.6
|
378.8 EU/mL
Interval 279.3 to 513.9
|
253.6 EU/mL
Interval 182.2 to 353.0
|
1.3 EU/mL
Interval 0.9 to 1.9
|
|
Antibody Concentrations for Anti-CS
Post Dose 3 (Month 3)
|
472.6 EU/mL
Interval 371.0 to 602.0
|
342.5 EU/mL
Interval 275.6 to 425.6
|
251.1 EU/mL
Interval 170.6 to 369.6
|
—
|
1.0 EU/mL
Interval 0.9 to 1.1
|
|
Antibody Concentrations for Anti-CS
Pre-Dose 3 (Month 7)
|
—
|
—
|
—
|
25.3 EU/mL
Interval 19.1 to 33.5
|
—
|
|
Antibody Concentrations for Anti-CS
Post Dose 3 (Month 8)
|
—
|
—
|
—
|
142.3 EU/mL
Interval 113.9 to 177.8
|
—
|
|
Antibody Concentrations for Anti-CS
Pre-Dose 4 (Month 14)
|
—
|
26.9 EU/mL
Interval 19.2 to 37.7
|
22.6 EU/mL
Interval 17.9 to 28.5
|
—
|
—
|
|
Antibody Concentrations for Anti-CS
Post Dose 4 (Month 15)
|
—
|
234.8 EU/mL
Interval 184.2 to 299.5
|
196.4 EU/mL
Interval 150.4 to 256.7
|
—
|
—
|
|
Antibody Concentrations for Anti-CS
Pre-Dose 4 (Month 20)
|
26.6 EU/mL
Interval 19.1 to 37.0
|
—
|
—
|
33.3 EU/mL
Interval 23.5 to 47.3
|
1.0 EU/mL
Interval 0.9 to 1.2
|
|
Antibody Concentrations for Anti-CS
Post Dose 4 (Month 21)
|
288.1 EU/mL
Interval 227.7 to 364.4
|
—
|
—
|
187.1 EU/mL
Interval 139.9 to 250.1
|
—
|
|
Antibody Concentrations for Anti-CS
Pre-Dose 5 (Month 26)
|
—
|
37.3 EU/mL
Interval 26.7 to 52.3
|
38.0 EU/mL
Interval 27.7 to 52.1
|
—
|
—
|
|
Antibody Concentrations for Anti-CS
Post Dose 5 (Month 27)
|
—
|
185.2 EU/mL
Interval 140.4 to 244.3
|
145.6 EU/mL
Interval 106.6 to 198.9
|
—
|
—
|
|
Antibody Concentrations for Anti-CS
Pre-Dose 5 (Month 32)
|
—
|
—
|
—
|
38.9 EU/mL
Interval 27.6 to 54.9
|
—
|
|
Antibody Concentrations for Anti-CS
Post Dose 5 (Month 33)
|
—
|
—
|
—
|
133.9 EU/mL
Interval 103.4 to 173.4
|
—
|
|
Antibody Concentrations for Anti-CS
Pre-Dose 6 (Month 38)
|
—
|
45.7 EU/mL
Interval 33.5 to 62.2
|
40.5 EU/mL
Interval 31.0 to 52.9
|
—
|
—
|
|
Antibody Concentrations for Anti-CS
Post Dose 6 (Month 39)
|
—
|
181.8 EU/mL
Interval 137.2 to 241.0
|
115.2 EU/mL
Interval 86.4 to 153.6
|
—
|
—
|
|
Antibody Concentrations for Anti-CS
End of Study (Month 50)
|
25.1 EU/mL
Interval 18.8 to 33.6
|
49.7 EU/mL
Interval 37.0 to 66.6
|
35.5 EU/mL
Interval 27.2 to 46.5
|
30.9 EU/mL
Interval 19.9 to 47.9
|
1.0 EU/mL
Interval 0.9 to 1.2
|
SECONDARY outcome
Timeframe: Before Dose 1, one month post-Dose 2, before and one month post-Dose 3, before and one month after Dose 4, before and one month after each yearly dose and at Study End (Month 50)Population: The analysis was performed on immunosubset which included all participants who complied with protocol defined procedures and for whom immunogenicity results were available for the specified time point and specific assay.
The antibody concentrations were calculated as GMCs and expressed as mlU/mL.
Outcome measures
| Measure |
Fx012-14-mFxD Group
n=45 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
R012-20 + R012-14 Group
n=49 Participants
Participants received full doses of RTS,S/AS01E at Month 0, Month 1, Month 2 and a full dose at Month 14, Month 20, Month 26, Month 38.
|
Fx012-14-mFxD Group
n=44 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
n=48 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
n=48 Participants
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
|---|---|---|---|---|---|
|
Antibody Concentrations for Anti-HB
Before Dose 1, Pre-Vaccination (Day 1)
|
162.8 mlU/mL
Interval 98.7 to 268.5
|
224.7 mlU/mL
Interval 142.3 to 354.7
|
124.6 mlU/mL
Interval 72.0 to 215.5
|
98.4 mlU/mL
Interval 55.7 to 173.8
|
152.5 mlU/mL
Interval 93.4 to 249.0
|
|
Antibody Concentrations for Anti-HB
Post Dose 2 (Month 2)
|
39990.7 mlU/mL
Interval 23198.3 to 68938.5
|
39336.5 mlU/mL
Interval 26109.5 to 59264.5
|
34301.2 mlU/mL
Interval 19896.6 to 59134.2
|
29015.8 mlU/mL
Interval 17445.6 to 48259.4
|
159.1 mlU/mL
Interval 83.8 to 302.2
|
|
Antibody Concentrations for Anti-HB
Post Dose 3 (Month 3)
|
45665.7 mlU/mL
Interval 26775.1 to 77884.4
|
37592.9 mlU/mL
Interval 27463.3 to 51458.8
|
21641.4 mlU/mL
Interval 12408.6 to 37743.9
|
—
|
100.4 mlU/mL
Interval 57.3 to 175.7
|
|
Antibody Concentrations for Anti-HB
Pre-Dose 3 (Month 7)
|
—
|
—
|
—
|
6296.7 mlU/mL
Interval 3817.3 to 10386.7
|
—
|
|
Antibody Concentrations for Anti-HB
Post Dose 3 (Month 8)
|
—
|
—
|
—
|
53700.6 mlU/mL
Interval 38222.8 to 75446.0
|
—
|
|
Antibody Concentrations for Anti-HB
Pre-Dose 4 (Month 14)
|
—
|
5700.6 mlU/mL
Interval 4033.4 to 8057.1
|
4856.5 mlU/mL
Interval 3129.3 to 7537.0
|
—
|
—
|
|
Antibody Concentrations for Anti-HB
Post Dose 4 (Month 15)
|
—
|
137582.9 mlU/mL
Interval 108671.7 to 174185.8
|
81612.1 mlU/mL
Interval 60532.7 to 110032.1
|
—
|
—
|
|
Antibody Concentrations for Anti-HB
Pre-Dose 4 (Month 20)
|
5189.6 mlU/mL
Interval 3061.3 to 8797.4
|
—
|
—
|
9700.1 mlU/mL
Interval 6732.0 to 13977.0
|
45.6 mlU/mL
Interval 26.6 to 78.3
|
|
Antibody Concentrations for Anti-HB
Post Dose 4 (Month 21)
|
210277.6 mlU/mL
Interval 160964.7 to 274697.9
|
—
|
—
|
74185.9 mlU/mL
Interval 55296.5 to 99528.0
|
—
|
|
Antibody Concentrations for Anti-HB
Pre-Dose 5 (Month 26)
|
—
|
18767.8 mlU/mL
Interval 14581.3 to 24156.3
|
14130.8 mlU/mL
Interval 9985.9 to 19996.1
|
—
|
—
|
|
Antibody Concentrations for Anti-HB
Post Dose 5 (Month 27)
|
—
|
126992.7 mlU/mL
Interval 101650.7 to 158652.5
|
63683.7 mlU/mL
Interval 42424.1 to 95596.9
|
—
|
—
|
|
Antibody Concentrations for Anti-HB
Pre-Dose 5 (Month 32)
|
—
|
—
|
—
|
13212.6 mlU/mL
Interval 9396.3 to 18579.0
|
—
|
|
Antibody Concentrations for Anti-HB
Post Dose 5 (Month 33)
|
—
|
—
|
—
|
57655.7 mlU/mL
Interval 44884.3 to 74060.9
|
—
|
|
Antibody Concentrations for Anti-HB
Pre-Dose 6 (Month 38)
|
—
|
24027.2 mlU/mL
Interval 18417.3 to 31345.9
|
16776.6 mlU/mL
Interval 11990.4 to 23473.1
|
—
|
—
|
|
Antibody Concentrations for Anti-HB
Post Dose 6 (Month 39)
|
—
|
114277.1 mlU/mL
Interval 88950.0 to 146815.7
|
60669.1 mlU/mL
Interval 42343.5 to 86925.7
|
—
|
—
|
|
Antibody Concentrations for Anti-HB
End of Study (Month 50)
|
10714.9 mlU/mL
Interval 7199.2 to 15947.3
|
24353.9 mlU/mL
Interval 18411.6 to 32214.0
|
13240.2 mlU/mL
Interval 9550.0 to 18356.2
|
10013.0 mlU/mL
Interval 6511.4 to 15397.7
|
18.5 mlU/mL
Interval 10.4 to 32.8
|
SECONDARY outcome
Timeframe: From Day 0 to Month 50Population: The analysis was performed on ES which included all participants who received at least one dose of study vaccine.
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related SAEs= Any SAE related to investigational vaccine or related to study participation or to a GSK concomitant medication/vaccine as assessed by the investigator. Fatal SAEs= Any SAEs leading to death.
Outcome measures
| Measure |
Fx012-14-mFxD Group
n=298 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
R012-20 + R012-14 Group
n=294 Participants
Participants received full doses of RTS,S/AS01E at Month 0, Month 1, Month 2 and a full dose at Month 14, Month 20, Month 26, Month 38.
|
Fx012-14-mFxD Group
n=304 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
n=311 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
n=293 Participants
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
|---|---|---|---|---|---|
|
Number of Participants With Any, Fatal and Related Serious Adverse Events (SAEs)
Fatal SAE
|
2 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Any, Fatal and Related Serious Adverse Events (SAEs)
Any SAE
|
73 Participants
|
65 Participants
|
64 Participants
|
84 Participants
|
92 Participants
|
|
Number of Participants With Any, Fatal and Related Serious Adverse Events (SAEs)
Related SAE
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Month 50Population: The analysis was performed on ES which included all participants who received at least one dose of study vaccine.
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Fx012-14-mFxD Group
n=298 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
R012-20 + R012-14 Group
n=294 Participants
Participants received full doses of RTS,S/AS01E at Month 0, Month 1, Month 2 and a full dose at Month 14, Month 20, Month 26, Month 38.
|
Fx012-14-mFxD Group
n=304 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
n=311 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
n=293 Participants
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
|---|---|---|---|---|---|
|
Number of Participants With Any Adverse Events (AEs) and SAEs Leading to Withdrawal From Further Vaccination
|
2 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Month 50Population: The analysis was performed on ES which included all participants who received at least one dose of study vaccine.
Cerebral malaria is defined as Severe P. falciparum malaria with coma (Blantyre coma score less than \[\<\] 3); and if malaria with seizure: coma persisting for \> 30 min after the seizure. Other treatable causes of coma should be excluded before diagnosing cerebral malaria (e.g. hypoglycaemia, bacterial meningitis). Severe malaria is defined as P. falciparum parasitemia \> 0 detected by microscopy and/or rapid diagnostic test (RDT) and one or more of the following, occurring in the absence of an identified alternative cause: Impaired consciousness, Prostration, Multiple convulsions, Acidosis, Hypoglycemia, Severe malarial anemia, Renal impairment, Jaundice, Pulmonary edema, Significant bleeding: including recurrent or prolonged bleeding from the nose, gums or venipuncture sites, hematemesis or melaena, Shock, Hyperparasitemia.
Outcome measures
| Measure |
Fx012-14-mFxD Group
n=298 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
R012-20 + R012-14 Group
n=294 Participants
Participants received full doses of RTS,S/AS01E at Month 0, Month 1, Month 2 and a full dose at Month 14, Month 20, Month 26, Month 38.
|
Fx012-14-mFxD Group
n=304 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
n=311 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
n=293 Participants
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
|---|---|---|---|---|---|
|
Number of Participants With Cerebral Malaria and Severe Malaria
Cerebral malaria
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Cerebral Malaria and Severe Malaria
Severe malaria
|
29 Participants
|
22 Participants
|
25 Participants
|
31 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Month 50Population: The analysis was performed on ES which included all participants who received at least one dose of study vaccine.
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Outcome measures
| Measure |
Fx012-14-mFxD Group
n=298 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
R012-20 + R012-14 Group
n=294 Participants
Participants received full doses of RTS,S/AS01E at Month 0, Month 1, Month 2 and a full dose at Month 14, Month 20, Month 26, Month 38.
|
Fx012-14-mFxD Group
n=304 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
n=311 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
n=293 Participants
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
|---|---|---|---|---|---|
|
Number of Participants With Potential Immune Mediated Diseases (pIMDs)
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Month 50Population: The analysis was performed on ES which included all participants who received at least one dose of study vaccine.
Meningitis is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders.
Outcome measures
| Measure |
Fx012-14-mFxD Group
n=298 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
R012-20 + R012-14 Group
n=294 Participants
Participants received full doses of RTS,S/AS01E at Month 0, Month 1, Month 2 and a full dose at Month 14, Month 20, Month 26, Month 38.
|
Fx012-14-mFxD Group
n=304 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
n=311 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
n=293 Participants
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
|---|---|---|---|---|---|
|
Number of Participants With Meningitis
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: During the 30-day (Day 0 to Day 29) follow-up period after any dose of study vaccinePopulation: The analysis was performed on ES which included all participants who received at least one dose of study vaccine.
Seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders.
Outcome measures
| Measure |
Fx012-14-mFxD Group
n=298 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
R012-20 + R012-14 Group
n=294 Participants
Participants received full doses of RTS,S/AS01E at Month 0, Month 1, Month 2 and a full dose at Month 14, Month 20, Month 26, Month 38.
|
Fx012-14-mFxD Group
n=304 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
n=311 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
n=293 Participants
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
|---|---|---|---|---|---|
|
Number of Participants With Seizures
|
5 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: During the 7-day (Day 0 to Day 6) follow-up period after any dose of study vaccinePopulation: The analysis was performed on ES which included all participants who received at least one dose of study vaccine.
Generalized convulsive seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders.
Outcome measures
| Measure |
Fx012-14-mFxD Group
n=298 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
R012-20 + R012-14 Group
n=294 Participants
Participants received full doses of RTS,S/AS01E at Month 0, Month 1, Month 2 and a full dose at Month 14, Month 20, Month 26, Month 38.
|
Fx012-14-mFxD Group
n=304 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
n=311 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
n=293 Participants
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
|---|---|---|---|---|---|
|
Number of Participants With Generalized Convulsive Seizures
|
4 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: During the 30-day (Day 0 to Day 29) follow-up period following the 1st 3 doses and post dose 4, 5 and 6 of study vaccinePopulation: The analysis was performed on ES which included all participants who received at least one dose of study vaccine and who had safety data available for the specific duration.
An unsolicited AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
Fx012-14-mFxD Group
n=298 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
R012-20 + R012-14 Group
n=294 Participants
Participants received full doses of RTS,S/AS01E at Month 0, Month 1, Month 2 and a full dose at Month 14, Month 20, Month 26, Month 38.
|
Fx012-14-mFxD Group
n=304 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
n=311 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
n=293 Participants
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
|---|---|---|---|---|---|
|
Number of Participants With Any Unsolicited AEs
Post Dose 4
|
74 Participants
|
94 Participants
|
101 Participants
|
79 Participants
|
—
|
|
Number of Participants With Any Unsolicited AEs
Post 1st 3 doses
|
223 Participants
|
221 Participants
|
240 Participants
|
242 Participants
|
238 Participants
|
|
Number of Participants With Any Unsolicited AEs
Post Dose 5
|
—
|
67 Participants
|
65 Participants
|
88 Participants
|
—
|
|
Number of Participants With Any Unsolicited AEs
Post Dose 6
|
—
|
64 Participants
|
76 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Before Dose 3 (at Month 2)Population: The analysis was performed on the reactogenicity sub-cohort, which included the first 50 participants enrolled in each group and for whom specific lab parameter data was available at a specific timepoint.
The assessed parameters (alanine aminotransferase \[ALT\], creatinine, haemoglobin, white blood cells \[WBC\], platelets) were summarized according to DAIDS, 2004 (Division of AIDS). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling. Data are presented for those participants who experienced Grade 4 toxicities. Grade 4 hematological toxicities included ALT: \> 10.0 x ULN (Upper limit of normal), creatine: \> 6.0 x ULN or requires dialysis, WBC: \< 1.0 x 103 per microliter, platelets: \< 25 x 103/μl and clinical signs of bleeding, and hemoglobin: \< 5.0 grams/deciliter and clinical signs of heart failure.
Outcome measures
| Measure |
Fx012-14-mFxD Group
n=46 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
R012-20 + R012-14 Group
n=48 Participants
Participants received full doses of RTS,S/AS01E at Month 0, Month 1, Month 2 and a full dose at Month 14, Month 20, Month 26, Month 38.
|
Fx012-14-mFxD Group
n=44 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
n=45 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
n=49 Participants
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
|---|---|---|---|---|---|
|
Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3
Haemoglobin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3
Platelets
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3
WBC
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3
ALT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3
Creatine
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At 7 days post-Dose 3Population: The analysis was performed on the reactogenicity sub-cohort, which included the first 50 participants enrolled in each group and for whom specific lab parameter data was available at a specific timepoint.
The assessed parameters (ALT, creatinine, haemoglobin, WBC, platelets) were summarized according to DAIDS, 2004 (Division of AIDS). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling. Data are presented for those participants who experienced Grade 4 toxicities. Grade 4 hematological toxicities included ALT: \> 10.0 x ULN, creatine: \> 6.0 x ULN or requires dialysis, WBC: \< 1.0 x 103 per microliter, platelets: \< 25 x 103/μl and clinical signs of bleeding, and hemoglobin: \< 5.0 grams/deciliter and clinical signs of heart failure.
Outcome measures
| Measure |
Fx012-14-mFxD Group
n=44 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
R012-20 + R012-14 Group
n=47 Participants
Participants received full doses of RTS,S/AS01E at Month 0, Month 1, Month 2 and a full dose at Month 14, Month 20, Month 26, Month 38.
|
Fx012-14-mFxD Group
n=43 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
n=41 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
n=48 Participants
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
|---|---|---|---|---|---|
|
Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3
Creatine
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3
Haemoglobin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3
Platelets
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3
WBC
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3
ALT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At 30 days post-Dose 3Population: The analysis was performed on the reactogenicity sub-cohort, which included the first 50 participants enrolled in each group and for whom specific lab parameter data was available at a specific timepoint.
The assessed parameters (ALT, creatinine, haemoglobin, WBC, platelets) were summarized according to DAIDS, 2004 (Division of AIDS). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling. Data are presented for those participants who experienced Grade 4 toxicities. Grade 4 hematological toxicities included ALT: \> 10.0 x ULN, creatine: \> 6.0 x ULN or requires dialysis, WBC: \< 1.0 x 103 per microliter, platelets: \< 25 x 103/μl and clinical signs of bleeding, and hemoglobin: \< 5.0 grams/deciliter and clinical signs of heart failure.
Outcome measures
| Measure |
Fx012-14-mFxD Group
n=38 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
R012-20 + R012-14 Group
n=45 Participants
Participants received full doses of RTS,S/AS01E at Month 0, Month 1, Month 2 and a full dose at Month 14, Month 20, Month 26, Month 38.
|
Fx012-14-mFxD Group
n=42 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
n=44 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
n=49 Participants
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
|---|---|---|---|---|---|
|
Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3
Haemoglobin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3
Platelets
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3
WBC
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3
ALT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3
Creatine
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0 to Day 3) follow-up period after Dose 3, Dose 4, Dose 5 and Dose 6 of study vaccinationPopulation: The analysis was performed on Solicited Safety Set reactogenicity sub-cohort (SSRS) which included all participants who received at least one dose of study vaccine and had solicited local data during specific duration.
Assessed solicited local AEs are: redness, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any redness and swelling = adverse event reported with a surface diameter \> 0 millimeters.
Outcome measures
| Measure |
Fx012-14-mFxD Group
n=46 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
R012-20 + R012-14 Group
n=48 Participants
Participants received full doses of RTS,S/AS01E at Month 0, Month 1, Month 2 and a full dose at Month 14, Month 20, Month 26, Month 38.
|
Fx012-14-mFxD Group
n=44 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
n=45 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
n=49 Participants
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
|---|---|---|---|---|---|
|
Number of Participants With Any Solicited Local Symptoms
Any Erythema, after Dose 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Solicited Local Symptoms
Any Erythema, after Dose 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Any Solicited Local Symptoms
Any Erythema, after Dose 5
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Any Solicited Local Symptoms
Any Erythema, after Dose 6
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Any Solicited Local Symptoms
Any Pain, after Dose 3
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Solicited Local Symptoms
Any Pain, after Dose 4
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
—
|
|
Number of Participants With Any Solicited Local Symptoms
Any Pain, after Dose 5
|
—
|
4 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Any Solicited Local Symptoms
Any Pain, after Dose 6
|
—
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Any Solicited Local Symptoms
Any Swelling, after Dose 3
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Any Solicited Local Symptoms
Any Swelling, after Dose 4
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Any Solicited Local Symptoms
Any Swelling, after Dose 5
|
—
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Any Solicited Local Symptoms
Any Swelling, after Dose 6
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0 to Day 3) follow-up period after Dose 3, Dose 4, Dose 5 and Dose 6 of study vaccinationPopulation: The analysis was performed on SSRS which included all participants who received at least one dose of study vaccine and had solicited general data during specific duration.
Assessed solicited general AEs are: drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination.
Outcome measures
| Measure |
Fx012-14-mFxD Group
n=46 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
R012-20 + R012-14 Group
n=48 Participants
Participants received full doses of RTS,S/AS01E at Month 0, Month 1, Month 2 and a full dose at Month 14, Month 20, Month 26, Month 38.
|
Fx012-14-mFxD Group
n=44 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
n=45 Participants
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
n=49 Participants
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
|---|---|---|---|---|---|
|
Number of Participants With Any Solicited General Symptoms
Any Loss of appetite, after Dose 6
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Any Solicited General Symptoms
Any Drowsiness, after Dose 5
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Any Solicited General Symptoms
Any Drowsiness, after Dose 3
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Any Solicited General Symptoms
Any Drowsiness, after Dose 4
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Any Solicited General Symptoms
Any Drowsiness, after Dose 6
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Any Solicited General Symptoms
Any Irritability/Fussiness, after Dose 3
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Any Solicited General Symptoms
Any Irritability/Fussiness, after Dose 4
|
0 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Any Solicited General Symptoms
Any Irritability/Fussiness, after Dose 5
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Any Solicited General Symptoms
Any Irritability/Fussiness, after Dose 6
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Any Solicited General Symptoms
Any Loss of appetite, after Dose 3
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Any Solicited General Symptoms
Any Loss of appetite, after Dose 4
|
2 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Any Solicited General Symptoms
Any Loss of appetite, after Dose 5
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
Adverse Events
R012-20 Group
Serious events: 73 serious events
Other events: 230 other events
Deaths: 2 deaths
R012-14-mD Group
Serious events: 65 serious events
Other events: 243 other events
Deaths: 1 deaths
Fx012-14-mFxD Group
Serious events: 64 serious events
Other events: 253 other events
Deaths: 0 deaths
Fx017-mFxD Group
Serious events: 84 serious events
Other events: 253 other events
Deaths: 4 deaths
Control Group
Serious events: 92 serious events
Other events: 234 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
R012-20 Group
n=298 participants at risk
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
|
R012-14-mD Group
n=294 participants at risk
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
|
Fx012-14-mFxD Group
n=304 participants at risk
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
n=311 participants at risk
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
n=293 participants at risk
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
|---|---|---|---|---|---|
|
Congenital, familial and genetic disorders
Cryptorchism
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Otitis media acute
|
1.0%
3/298 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.99%
3/304 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Plasmodium falciparum infection
|
9.4%
28/298 • Number of events 28 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
7.5%
22/294 • Number of events 22 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
9.5%
29/304 • Number of events 29 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
10.3%
32/311 • Number of events 32 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
16.4%
48/293 • Number of events 48 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Pneumonia
|
5.0%
15/298 • Number of events 15 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
5.1%
15/294 • Number of events 15 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
3.9%
12/304 • Number of events 12 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
3.2%
10/311 • Number of events 10 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
7.2%
21/293 • Number of events 21 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Gastroenteritis
|
4.0%
12/298 • Number of events 12 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
3.1%
9/294 • Number of events 9 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
3.0%
9/304 • Number of events 9 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
4.8%
15/311 • Number of events 15 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
4.4%
13/293 • Number of events 13 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Malaria
|
2.7%
8/298 • Number of events 8 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
2.4%
7/294 • Number of events 7 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
2.0%
6/304 • Number of events 6 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
3.2%
10/311 • Number of events 10 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
4.1%
12/293 • Number of events 12 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Otitis media
|
1.3%
4/298 • Number of events 4 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.0%
3/294 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.3%
4/304 • Number of events 4 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.3%
4/311 • Number of events 4 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.7%
5/293 • Number of events 5 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Urinary tract infection
|
1.0%
3/298 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.66%
2/304 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.96%
3/311 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.7%
5/293 • Number of events 5 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Cellulitis
|
1.0%
3/298 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/294 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.66%
2/304 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/293 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Abscess limb
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.66%
2/304 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.96%
3/311 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/293 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Meningitis viral
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.64%
2/311 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.0%
3/293 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.99%
3/304 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.96%
3/311 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Dysentery
|
0.67%
2/298 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.66%
2/304 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Bacterial infection
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/293 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/294 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/293 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Skin bacterial infection
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.96%
3/311 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Sepsis
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/294 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.66%
2/304 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Bronchiolitis
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Meningitis
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.64%
2/311 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Abscess neck
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Cellulitis orbital
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Pyomyositis
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Amoebic dysentery
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Bullous impetigo
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Cerebral malaria
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Ear infection
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Encephalitis
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Joint abscess
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Klebsiella sepsis
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Mastoid abscess
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Meningitis enteroviral
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Salmonella sepsis
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Superinfection bacterial
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Tinea capitis
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Typhoid fever
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Nervous system disorders
Febrile convulsion
|
3.4%
10/298 • Number of events 10 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.4%
4/294 • Number of events 4 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
2.0%
6/304 • Number of events 6 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
3.9%
12/311 • Number of events 12 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
3.8%
11/293 • Number of events 11 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Nervous system disorders
Seizure
|
1.0%
3/298 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/294 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Nervous system disorders
Tonic convulsion
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
5/298 • Number of events 5 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.4%
4/294 • Number of events 4 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.3%
4/304 • Number of events 4 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.3%
4/311 • Number of events 4 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
3.8%
11/293 • Number of events 11 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Blood and lymphatic system disorders
Intravascular haemolysis
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Blood and lymphatic system disorders
Hypersplenism
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Blood and lymphatic system disorders
Abdominal lymphadenopathy
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.0%
3/294 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.64%
2/311 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.7%
5/293 • Number of events 5 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.66%
2/304 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Electric shock
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Eyelid abrasion
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Foreign body in gastrointestinal tract
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Foreign body in mouth
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Hyphaema
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/293 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Gastrointestinal disorders
Anal skin tags
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Gastrointestinal disorders
Strangulated umbilical hernia
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.66%
2/304 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/293 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/293 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Acute chest syndrome
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.66%
2/304 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Renal and urinary disorders
Urethral polyp
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Renal and urinary disorders
Urethral prolapse
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/293 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
General disorders
Drowning
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
General disorders
Hernia
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Musculoskeletal and connective tissue disorders
Fracture malunion
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Immune system disorders
Allergy to arthropod sting
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Reproductive system and breast disorders
Testicular retraction
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
Other adverse events
| Measure |
R012-20 Group
n=298 participants at risk
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
|
R012-14-mD Group
n=294 participants at risk
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
|
Fx012-14-mFxD Group
n=304 participants at risk
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
|
Fx017-mFxD Group
n=311 participants at risk
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
|
Control Group
n=293 participants at risk
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
|
|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
54.0%
161/298 • Number of events 238 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
63.6%
187/294 • Number of events 320 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
65.1%
198/304 • Number of events 377 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
62.4%
194/311 • Number of events 323 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
56.0%
164/293 • Number of events 237 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Malaria
|
25.5%
76/298 • Number of events 101 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
29.3%
86/294 • Number of events 142 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
32.2%
98/304 • Number of events 147 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
30.2%
94/311 • Number of events 142 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
21.5%
63/293 • Number of events 90 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Gastroenteritis
|
18.8%
56/298 • Number of events 65 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
29.6%
87/294 • Number of events 107 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
25.0%
76/304 • Number of events 95 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
22.5%
70/311 • Number of events 86 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
23.2%
68/293 • Number of events 80 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Pneumonia
|
6.4%
19/298 • Number of events 20 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
13.9%
41/294 • Number of events 44 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
12.5%
38/304 • Number of events 42 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
8.4%
26/311 • Number of events 28 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
11.3%
33/293 • Number of events 34 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Conjunctivitis
|
8.1%
24/298 • Number of events 26 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
10.9%
32/294 • Number of events 35 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
11.5%
35/304 • Number of events 37 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
7.1%
22/311 • Number of events 23 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
9.2%
27/293 • Number of events 28 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Otitis media
|
7.7%
23/298 • Number of events 25 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
8.5%
25/294 • Number of events 29 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
10.9%
33/304 • Number of events 37 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
6.8%
21/311 • Number of events 24 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
11.3%
33/293 • Number of events 38 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Skin bacterial infection
|
6.0%
18/298 • Number of events 20 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
8.5%
25/294 • Number of events 29 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
9.5%
29/304 • Number of events 35 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
5.1%
16/311 • Number of events 18 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
5.5%
16/293 • Number of events 18 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Respiratory tract infection
|
6.0%
18/298 • Number of events 19 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
5.1%
15/294 • Number of events 16 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
5.3%
16/304 • Number of events 16 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
3.2%
10/311 • Number of events 10 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
3.8%
11/293 • Number of events 11 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Rash pustular
|
3.0%
9/298 • Number of events 9 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
4.1%
12/294 • Number of events 12 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
3.6%
11/304 • Number of events 13 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
5.5%
17/311 • Number of events 18 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
3.8%
11/293 • Number of events 11 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Body tinea
|
1.3%
4/298 • Number of events 4 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
3.7%
11/294 • Number of events 12 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
3.6%
11/304 • Number of events 11 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
2.9%
9/311 • Number of events 9 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
3.8%
11/293 • Number of events 12 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Septic rash
|
3.4%
10/298 • Number of events 12 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
3.1%
9/294 • Number of events 11 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
3.3%
10/304 • Number of events 10 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
3.5%
11/311 • Number of events 11 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/293 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Tinea capitis
|
2.7%
8/298 • Number of events 8 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
3.1%
9/294 • Number of events 10 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
2.6%
8/304 • Number of events 8 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.6%
5/311 • Number of events 5 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.0%
3/293 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Urinary tract infection
|
2.0%
6/298 • Number of events 6 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
2.7%
8/294 • Number of events 9 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
2.3%
7/304 • Number of events 7 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
2.0%
6/293 • Number of events 6 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Oral candidiasis
|
2.0%
6/298 • Number of events 6 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.7%
5/294 • Number of events 5 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.66%
2/304 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
2.4%
7/293 • Number of events 7 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Lower respiratory tract infection
|
1.3%
4/298 • Number of events 4 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.7%
5/294 • Number of events 5 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.3%
4/304 • Number of events 4 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.64%
2/311 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.0%
3/293 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Abscess
|
2.0%
6/298 • Number of events 6 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.4%
4/294 • Number of events 4 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.66%
2/304 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.96%
3/311 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/293 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Dysentery
|
0.67%
2/298 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.4%
4/294 • Number of events 4 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.6%
5/304 • Number of events 5 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.96%
3/311 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.0%
3/293 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Tonsillitis
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.7%
5/294 • Number of events 5 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.66%
2/304 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.96%
3/311 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.0%
3/293 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Rhinitis
|
1.0%
3/298 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.7%
5/294 • Number of events 5 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.99%
3/304 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Viral infection
|
1.0%
3/298 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/294 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.96%
3/311 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/293 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/294 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.66%
2/304 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.6%
5/311 • Number of events 5 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/293 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Acarodermatitis
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/294 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.6%
5/304 • Number of events 5 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Helminthic infection
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.0%
3/294 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.3%
4/304 • Number of events 4 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Otitis externa
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.99%
3/304 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.3%
4/311 • Number of events 4 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/293 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Furuncle
|
1.3%
4/298 • Number of events 4 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.64%
2/311 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Cellulitis
|
0.67%
2/298 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.66%
2/304 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Viral rash
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.64%
2/311 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/293 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.66%
2/304 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/293 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Varicella
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.0%
3/293 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Abscess limb
|
0.67%
2/298 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.66%
2/304 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Fungal skin infection
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Cutaneous larva migrans
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.66%
2/304 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Skin infection
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.66%
2/304 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Tinea pedis
|
0.67%
2/298 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Bullous impetigo
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/294 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Ear infection
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.64%
2/311 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Hordeolum
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Dermatitis infected
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Ecthyma
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Fungal infection
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Gastroenteritis cryptosporidial
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Impetigo
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Joint abscess
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Measles
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Mumps
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Pharyngotonsillitis
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Plasmodium falciparum infection
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Pyomyositis
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Sepsis
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Superinfection
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Taeniasis
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
8.7%
26/298 • Number of events 27 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
10.2%
30/294 • Number of events 35 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
8.9%
27/304 • Number of events 28 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
7.1%
22/311 • Number of events 25 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
8.2%
24/293 • Number of events 25 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.67%
2/298 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
2.0%
6/294 • Number of events 7 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.99%
3/304 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
2.6%
8/311 • Number of events 8 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.0%
3/293 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.67%
2/298 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
3.4%
10/294 • Number of events 10 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.99%
3/304 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.64%
2/311 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.0%
3/293 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.0%
3/294 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.99%
3/304 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.3%
4/311 • Number of events 4 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/293 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.6%
5/311 • Number of events 5 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/293 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
1.3%
4/298 • Number of events 5 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.66%
2/304 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/293 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.0%
3/293 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.67%
2/298 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.96%
3/311 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/294 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.66%
2/304 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.0%
3/294 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
General disorders
Pyrexia
|
11.7%
35/298 • Number of events 41 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
23.5%
69/294 • Number of events 103 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
11.8%
36/304 • Number of events 43 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
13.8%
43/311 • Number of events 49 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
4.4%
13/293 • Number of events 14 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
General disorders
Injection site pain
|
1.3%
4/298 • Number of events 4 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
3.1%
9/294 • Number of events 12 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.66%
2/304 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.3%
4/311 • Number of events 4 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
General disorders
Injection site swelling
|
1.0%
3/298 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.4%
4/294 • Number of events 5 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.64%
2/311 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
General disorders
Irritability postvaccinal
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
2.0%
6/294 • Number of events 7 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.3%
4/311 • Number of events 4 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
General disorders
Chest pain
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
General disorders
Injection site erythema
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
General disorders
Peripheral swelling
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
General disorders
Swelling
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
General disorders
Xerosis
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Gastrointestinal disorders
Diarrhoea
|
10.1%
30/298 • Number of events 34 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
8.5%
25/294 • Number of events 26 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
13.2%
40/304 • Number of events 44 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
8.4%
26/311 • Number of events 30 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
11.9%
35/293 • Number of events 41 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
6/298 • Number of events 6 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.0%
3/294 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
2.3%
7/304 • Number of events 8 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.96%
3/311 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.7%
5/293 • Number of events 5 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/294 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.96%
3/311 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Gastrointestinal disorders
Stomatitis
|
0.67%
2/298 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/294 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.66%
2/304 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.66%
2/304 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/293 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Gastrointestinal disorders
Enteritis
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/293 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/294 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Blood and lymphatic system disorders
Anaemia
|
4.0%
12/298 • Number of events 12 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
3.1%
9/294 • Number of events 9 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
3.3%
10/304 • Number of events 11 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
5.5%
17/311 • Number of events 19 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
3.8%
11/293 • Number of events 11 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.7%
8/298 • Number of events 10 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
2.7%
8/294 • Number of events 8 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
3.9%
12/304 • Number of events 14 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
2.3%
7/311 • Number of events 8 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
2.0%
6/293 • Number of events 7 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.66%
2/304 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.64%
2/311 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Allergic cough
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.67%
2/298 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/294 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.3%
4/304 • Number of events 4 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.6%
5/311 • Number of events 5 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Wound
|
0.67%
2/298 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.0%
3/294 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/293 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/294 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.64%
2/311 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/293 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Chemical burns of eye
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Foreign body in respiratory tract
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Injury, poisoning and procedural complications
Tooth injury
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.67%
2/298 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
3.1%
9/294 • Number of events 9 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
2.3%
7/304 • Number of events 7 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.64%
2/311 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Eye disorders
Conjunctivitis allergic
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
1.4%
4/294 • Number of events 4 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.96%
3/311 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Eye disorders
Vernal keratoconjunctivitis
|
0.34%
1/298 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Eye disorders
Eye allergy
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.32%
1/311 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Nervous system disorders
Somnolence
|
0.67%
2/298 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/294 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.66%
2/304 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.64%
2/311 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.64%
2/311 • Number of events 2 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Psychiatric disorders
Irritability
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.68%
2/294 • Number of events 3 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/294 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Investigations
Blood creatinine increased
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/304 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.34%
1/293 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
|
Musculoskeletal and connective tissue disorders
Bone swelling
|
0.00%
0/298 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/294 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.33%
1/304 • Number of events 1 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/311 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
0.00%
0/293 • Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER