Trial Outcomes & Findings for A Study on the Immune Response, Safety and the Occurrence of Respiratory Syncytial Virus (RSV)-Associated Respiratory Tract Illness After Administration of RSV OA Vaccine in Adults 60 Years and Older (NCT NCT06551181)
NCT ID: NCT06551181
Last Updated: 2026-05-19
Results Overview
RSV-A neutralizing titers were determined by neutralization assay and the results were expressed as GMTs. Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model includes treatment group as fixed effect, and the pre-dose log10-transformed titers as a covariate.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2620 participants
Primary outcome timeframe
At Day 31
Results posted on
2026-05-19
Participant Flow
Analysis presented includes data up to Primary Completion. Additional results will be provided within one year of study completion.
Participant milestones
| Measure |
RSV OA Vaccine Group (Overseas)
Overseas older adults (OA) participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6).
|
RSV OA Vaccine Group (China)
Chinese OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6 or last acute respiratory illness (ARI) visit/contact, whichever was later).
|
Placebo Group (China)
Chinese OA participants received a single dose of placebo at Day 1 and were followed up until end of study (Month 6 or last ARI visit/contact, whichever was later).
|
|---|---|---|---|
|
Overall Study
STARTED
|
820
|
1199
|
601
|
|
Overall Study
COMPLETED
|
812
|
1176
|
589
|
|
Overall Study
NOT COMPLETED
|
8
|
23
|
12
|
Reasons for withdrawal
| Measure |
RSV OA Vaccine Group (Overseas)
Overseas older adults (OA) participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6).
|
RSV OA Vaccine Group (China)
Chinese OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6 or last acute respiratory illness (ARI) visit/contact, whichever was later).
|
Placebo Group (China)
Chinese OA participants received a single dose of placebo at Day 1 and were followed up until end of study (Month 6 or last ARI visit/contact, whichever was later).
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
|
Overall Study
Death
|
2
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
17
|
10
|
|
Overall Study
Other
|
0
|
1
|
1
|
Baseline Characteristics
A Study on the Immune Response, Safety and the Occurrence of Respiratory Syncytial Virus (RSV)-Associated Respiratory Tract Illness After Administration of RSV OA Vaccine in Adults 60 Years and Older
Baseline characteristics by cohort
| Measure |
RSV OA Vaccine Group (Overseas)
n=820 Participants
Overseas older adults (OA) participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6).
|
RSV OA Vaccine Group (China)
n=1199 Participants
Chinese OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6 or last acute respiratory illness (ARI) visit/contact, whichever was later).
|
Placebo Group (China)
n=601 Participants
Chinese OA participants received a single dose of placebo at Day 1 and were followed up until end of study (Month 6 or last ARI visit/contact, whichever was later).
|
Total
n=2620 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex: Female, Male
Male
|
381 Participants
n=30 Participants
|
581 Participants
n=30 Participants
|
297 Participants
n=60 Participants
|
1259 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
Asian
|
106 Participants
n=30 Participants
|
1199 Participants
n=30 Participants
|
601 Participants
n=60 Participants
|
1906 Participants
n=133 Participants
|
|
Age, Continuous
|
70.5 YEARS
STANDARD_DEVIATION 6.8 • n=30 Participants
|
69.8 YEARS
STANDARD_DEVIATION 6.6 • n=30 Participants
|
69.9 YEARS
STANDARD_DEVIATION 6.7 • n=60 Participants
|
70.1 YEARS
STANDARD_DEVIATION 6.7 • n=133 Participants
|
|
Sex: Female, Male
Female
|
439 Participants
n=30 Participants
|
618 Participants
n=30 Participants
|
304 Participants
n=60 Participants
|
1361 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
White
|
707 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
707 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
3 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
3 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
4 Participants
n=133 Participants
|
PRIMARY outcome
Timeframe: At Day 31Population: Analysis performed on Per Protocol Set(PPS)-all eligible participants who received study intervention,had immunogenicity results pre\&post dose,complied with blood draw intervals,without intercurrent conditions that may interfere with immunogenicity \& without prohibited concomitant medication.As pre-specified in Protocol,analysis was performed only on RSV OA vaccine (China) \& RSV OA vaccine (Oversea) groups.Participants with adjusted RSV-A GMTs data available at specified timepoint were reported.
RSV-A neutralizing titers were determined by neutralization assay and the results were expressed as GMTs. Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model includes treatment group as fixed effect, and the pre-dose log10-transformed titers as a covariate.
Outcome measures
| Measure |
RSV OA Vaccine Group (China)
n=1175 Participants
Chinese OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6 or last acute respiratory illness (ARI) visit/contact, whichever was later).
|
RSV OA Vaccine Group (Overseas)
n=757 Participants
Overseas OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6).
|
Placebo Group (China)
Chinese OA participants received a single dose of placebo at Day 1 and were followed up until end of study (Month 6 or last ARI visit/contact, whichever was later).
|
|---|---|---|---|
|
RSV-A Neutralizing Titers Expressed as Adjusted Geometric Mean Titers (GMTs) at 1 Month Post RSVPreF3 OA Vaccination
|
5676.7 Titer
Interval 5419.3 to 5946.2
|
6329.5 Titer
Interval 5973.7 to 6706.5
|
—
|
PRIMARY outcome
Timeframe: At Day 31 compared to baseline (Day 1)Population: Analysis was performed on the PPS. As pre-specified in the Protocol, the analysis was performed only on the RSV OA vaccine Group (China) and RSV OA vaccine Group (Overseas). Participants with data available for seroresponse for RSV-A at the specified timepoint were reported in this outcome measure.
Seroresponse was defined as at least a 4 fold (≥4) increase in neutralizing titers (1 month post-study intervention administration over pre-study intervention administration).
Outcome measures
| Measure |
RSV OA Vaccine Group (China)
n=1175 Participants
Chinese OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6 or last acute respiratory illness (ARI) visit/contact, whichever was later).
|
RSV OA Vaccine Group (Overseas)
n=757 Participants
Overseas OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6).
|
Placebo Group (China)
Chinese OA participants received a single dose of placebo at Day 1 and were followed up until end of study (Month 6 or last ARI visit/contact, whichever was later).
|
|---|---|---|---|
|
Percentage of Participants With Seroresponse for RSV-A Neutralizing Titers at 1 Month Post RSVPreF3 OA Vaccination
|
77.3 Percentage of participants
Interval 74.8 to 79.6
|
76.9 Percentage of participants
Interval 73.7 to 79.8
|
—
|
PRIMARY outcome
Timeframe: At Day 31Population: Analysis was performed on the PPS. As pre-specified in the Protocol, the analysis was performed only on the RSV OA vaccine Group (China) and RSV OA vaccine Group (Overseas). Participants with adjusted RSV-B GMTs data available at the specified timepoint were reported in this outcome measure.
RSV-B neutralizing titers were determined by neutralization assay and the results were expressed as GMTs. Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model includes treatment group as fixed effect, and the pre-dose log10-transformed titers as a covariate.
Outcome measures
| Measure |
RSV OA Vaccine Group (China)
n=1175 Participants
Chinese OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6 or last acute respiratory illness (ARI) visit/contact, whichever was later).
|
RSV OA Vaccine Group (Overseas)
n=757 Participants
Overseas OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6).
|
Placebo Group (China)
Chinese OA participants received a single dose of placebo at Day 1 and were followed up until end of study (Month 6 or last ARI visit/contact, whichever was later).
|
|---|---|---|---|
|
RSV-B Neutralizing Titers Expressed as Adjusted GMTs at 1 Month Post RSVPreF3 OA Vaccination
|
8072.8 Titer
Interval 7710.8 to 8451.9
|
8286.8 Titer
Interval 7826.4 to 8774.3
|
—
|
PRIMARY outcome
Timeframe: At Day 31 compared to baseline (Day 1)Population: Analysis was performed on the PPS. As pre-specified in the Protocol, the analysis was performed only on the RSV OA vaccine Group (China) and RSV OA vaccine Group (Overseas). Participants with data available for seroresponse for RSV-B at the specified timepoint were reported in this outcome measure.
Outcome measures
| Measure |
RSV OA Vaccine Group (China)
n=1175 Participants
Chinese OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6 or last acute respiratory illness (ARI) visit/contact, whichever was later).
|
RSV OA Vaccine Group (Overseas)
n=757 Participants
Overseas OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6).
|
Placebo Group (China)
Chinese OA participants received a single dose of placebo at Day 1 and were followed up until end of study (Month 6 or last ARI visit/contact, whichever was later).
|
|---|---|---|---|
|
Percentage of Participants With Seroresponse for RSV-B Neutralizing Titers at 1 Month Post RSVPreF3 OA Vaccination
|
69.5 Percentage of participants
Interval 66.8 to 72.2
|
70.3 Percentage of participants
Interval 66.9 to 73.5
|
—
|
SECONDARY outcome
Timeframe: At Day 1 (baseline) and Day 31 (1 month post RSVPreF3 OA vaccination)Population: Analysis was performed on the PPS. As pre-specified in the Protocol, the analysis was performed only on the RSV OA vaccine Group (China) and RSV OA vaccine Group (Overseas). Participants with unadjusted RSV-A GMT data available at the specified timepoints (Day 1 and Day 31) were reported in this outcome measure.
Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. Unadjusted GMT is a descriptive statistic calculated directly from the observed titer values at pre-vaccination and at 1-month post-vaccination timepoints for all participants in the analysis set, without any statistical modelling or adjustment for covariates.
Outcome measures
| Measure |
RSV OA Vaccine Group (China)
n=1191 Participants
Chinese OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6 or last acute respiratory illness (ARI) visit/contact, whichever was later).
|
RSV OA Vaccine Group (Overseas)
n=816 Participants
Overseas OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6).
|
Placebo Group (China)
Chinese OA participants received a single dose of placebo at Day 1 and were followed up until end of study (Month 6 or last ARI visit/contact, whichever was later).
|
|---|---|---|---|
|
RSV-A Neutralizing Titers Expressed as Unadjusted GMTs at Baseline and 1 Month Post RSVPreF3 OA Vaccination
Day 1 (Baseline)
|
703.3 Titer
Interval 674.0 to 733.9
|
825.8 Titer
Interval 776.6 to 878.1
|
—
|
|
RSV-A Neutralizing Titers Expressed as Unadjusted GMTs at Baseline and 1 Month Post RSVPreF3 OA Vaccination
Day 31
|
5523.2 Titer
Interval 5254.7 to 5805.5
|
6604.5 Titer
Interval 6194.4 to 7041.7
|
—
|
SECONDARY outcome
Timeframe: At Day 1 (baseline) and Day 31 (1 month post RSVPreF3 OA vaccination)Population: Analysis was performed on the PPS. As pre-specified in the Protocol, the analysis was performed only on the RSV OA vaccine Group (China) and RSV OA vaccine Group (Overseas). Participants with unadjusted RSV-B GMT data available at the specified timepoints (Day 1 and Day 31) were reported in this outcome measure.
Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. Unadjusted GMT is a descriptive statistic calculated directly from the observed titer values at pre-vaccination and at 1-month post-vaccination timepoints for all participants in the analysis set, without any statistical modelling or adjustment for covariates.
Outcome measures
| Measure |
RSV OA Vaccine Group (China)
n=1191 Participants
Chinese OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6 or last acute respiratory illness (ARI) visit/contact, whichever was later).
|
RSV OA Vaccine Group (Overseas)
n=816 Participants
Overseas OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6).
|
Placebo Group (China)
Chinese OA participants received a single dose of placebo at Day 1 and were followed up until end of study (Month 6 or last ARI visit/contact, whichever was later).
|
|---|---|---|---|
|
RSV-B Neutralizing Titers Expressed as Unadjusted GMTs at Baseline and 1 Month Post RSVPreF3 OA Vaccination
Day 1 (Baseline)
|
1264.9 Titer
Interval 1209.8 to 1322.6
|
1274.2 Titer
Interval 1194.6 to 1359.0
|
—
|
|
RSV-B Neutralizing Titers Expressed as Unadjusted GMTs at Baseline and 1 Month Post RSVPreF3 OA Vaccination
Day 31
|
8073.2 Titer
Interval 7680.5 to 8485.9
|
8286.2 Titer
Interval 7766.3 to 8840.9
|
—
|
SECONDARY outcome
Timeframe: At Day 181 (6 months post RSVPreF3 OA vaccination)Data not available at the time of initial results posting, will be updated at the final results disclosure stage.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Day 31 compared to baseline (Day 1)Population: Analysis was performed on the PPS. As pre-specified in the Protocol, the analysis was performed only on the RSV OA vaccine Group (China) and RSV OA vaccine Group (Overseas). Participants with data available for seroresponse for RSV-A and RSV-B at the specified timepoint were reported in this outcome measure.
Outcome measures
| Measure |
RSV OA Vaccine Group (China)
n=1175 Participants
Chinese OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6 or last acute respiratory illness (ARI) visit/contact, whichever was later).
|
RSV OA Vaccine Group (Overseas)
n=786 Participants
Overseas OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6).
|
Placebo Group (China)
Chinese OA participants received a single dose of placebo at Day 1 and were followed up until end of study (Month 6 or last ARI visit/contact, whichever was later).
|
|---|---|---|---|
|
Percentage of Participants With Seroresponse for RSV-A and RSV-B Neutralizing Titers at 1 Month Post RSVPreF3 OA Vaccination
RSV-A, Day 31
|
77.3 Percentage of participants
Interval 74.8 to 79.6
|
76.9 Percentage of participants
Interval 73.7 to 79.8
|
—
|
|
Percentage of Participants With Seroresponse for RSV-A and RSV-B Neutralizing Titers at 1 Month Post RSVPreF3 OA Vaccination
RSV-B, Day 31
|
69.5 Percentage of participants
Interval 66.8 to 72.2
|
70.3 Percentage of participants
Interval 66.9 to 73.5
|
—
|
SECONDARY outcome
Timeframe: At Day 181 compared to baseline (Day 1)Data not available at the time of initial results posting, will be updated at the final results disclosure stage.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Day 31Population: Analysis was performed on the PPS. Only participants from RSV OA vaccine Group (China) and the immunogenicity subset of the global RSV OA=ADJ-006 study \[RSV OA Overseas (RSV OA=ADJ-006 study)\] with data available for adjusted RSV-A and RSV-B GMTs at the specified timepoint (Day 31) were reported in this outcome measure.
This outcome measure compares the adjusted GMTs for RSV-A and RSV-B for the RSV OA vaccine Group (China) to the selected immunogenicity subset of the global efficacy study RSV OA=ADJ-006 \[RSV OA Overseas (RSV OA=ADJ-006 study) group\]. Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model includes treatment group as fixed effect, and the pre-dose log10-transformed titers as a covariate.
Outcome measures
| Measure |
RSV OA Vaccine Group (China)
n=1175 Participants
Chinese OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6 or last acute respiratory illness (ARI) visit/contact, whichever was later).
|
RSV OA Vaccine Group (Overseas)
n=832 Participants
Overseas OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6).
|
Placebo Group (China)
Chinese OA participants received a single dose of placebo at Day 1 and were followed up until end of study (Month 6 or last ARI visit/contact, whichever was later).
|
|---|---|---|---|
|
RSV-A and RSV-B Neutralizing Titers Expressed as Adjusted GMTs at 1 Month Post RSVPreF3 OA Vaccination Between RSV OA Overseas (RSV OA=ADJ-006 Study) vs RSV OA Vaccine Group (China) Group
RSV-A
|
5790.3 Titer
Interval 5505.8 to 6089.4
|
8670.5 Titer
Interval 8165.7 to 9206.6
|
—
|
|
RSV-A and RSV-B Neutralizing Titers Expressed as Adjusted GMTs at 1 Month Post RSVPreF3 OA Vaccination Between RSV OA Overseas (RSV OA=ADJ-006 Study) vs RSV OA Vaccine Group (China) Group
RSV-B
|
7975.1 Titer
Interval 7611.5 to 8356.0
|
10281.3 Titer
Interval 9726.6 to 10867.6
|
—
|
SECONDARY outcome
Timeframe: At Day 31 compared to baseline (Day 1)Population: Analysis was performed on the PPS. Only participants from RSV OA vaccine Group (China) and the immunogenicity subset of the global RSV OA=ADJ-006 study \[RSV OA Overseas (RSV OA=ADJ-006 study)\] with data available for seroresponse for RSV-A and RSV-B at the specified timepoints (Day 1 and Day 31) were reported in this outcome measure.
This outcome measure compares the seroresponse for RSV-A and RSV-B neutralizing titers in the RSV OA vaccine Group (China) group to the selected immunogenicity subset of the global efficacy study RSV OA=ADJ-006 \[RSV OA Overseas (RSV OA=ADJ-006 study) group\].
Outcome measures
| Measure |
RSV OA Vaccine Group (China)
n=1175 Participants
Chinese OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6 or last acute respiratory illness (ARI) visit/contact, whichever was later).
|
RSV OA Vaccine Group (Overseas)
n=832 Participants
Overseas OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6).
|
Placebo Group (China)
Chinese OA participants received a single dose of placebo at Day 1 and were followed up until end of study (Month 6 or last ARI visit/contact, whichever was later).
|
|---|---|---|---|
|
Percentage of Participants With Seroresponse for RSV-A and RSV-B Neutralizing Titers at 1 Month Post RSVPreF3 OA Vaccination Between RSV OA Overseas (RSV OA=ADJ-006 Study) vs RSV OA Vaccine Group (China) Group
RSV-A
|
77.3 Percentage of participants
Interval 74.8 to 79.6
|
81.6 Percentage of participants
Interval 78.8 to 84.2
|
—
|
|
Percentage of Participants With Seroresponse for RSV-A and RSV-B Neutralizing Titers at 1 Month Post RSVPreF3 OA Vaccination Between RSV OA Overseas (RSV OA=ADJ-006 Study) vs RSV OA Vaccine Group (China) Group
RSV-B
|
69.5 Percentage of participants
Interval 66.8 to 72.2
|
78.6 Percentage of participants
Interval 75.7 to 81.3
|
—
|
SECONDARY outcome
Timeframe: From Day 15 and up to study end (6 months post dose [dose administered at Day 1])Data not available at the time of initial results posting, will be updated at the final results disclosure stage.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 15 and up to study end (6 months post dose [dose administered at Day 1])Data not available at the time of initial results posting, will be updated at the final results disclosure stage.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 15 and up to study end (6 months post dose [dose administered at Day 1])Data not available at the time of initial results posting, will be updated at the final results disclosure stage.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 15 and up to study end (6 months post dose [dose administered at Day 1])Data not available at the time of initial results posting, will be updated at the final results disclosure stage.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 15 and up to study end (6 months post dose [dose administered at Day 1])Data not available at the time of initial results posting, will be updated at the final results disclosure stage.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 15 and up to study end (6 months post dose [dose administered at Day 1])Data not available at the time of initial results posting, will be updated at the final results disclosure stage.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 (baseline) to Day 7Population: Analysis was performed on the ES. As pre-specified in Protocol, data for this outcome measure were collected only for the Chinese groups (RSV OA vaccine Group \[China\] and Placebo Group \[China\]), from which only those participants with data available for solicited administration site adverse events at the specified time period were reported in this outcome measure.
Assessed solicited administration site adverse events were pain, redness (erythema) and swelling at administration site. Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
RSV OA Vaccine Group (China)
n=1193 Participants
Chinese OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6 or last acute respiratory illness (ARI) visit/contact, whichever was later).
|
RSV OA Vaccine Group (Overseas)
n=599 Participants
Overseas OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6).
|
Placebo Group (China)
Chinese OA participants received a single dose of placebo at Day 1 and were followed up until end of study (Month 6 or last ARI visit/contact, whichever was later).
|
|---|---|---|---|
|
Number of Participants Reporting Any Solicited Administration Site Adverse Events
Erythema
|
88 Participants
|
3 Participants
|
—
|
|
Number of Participants Reporting Any Solicited Administration Site Adverse Events
Swelling
|
82 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Any Solicited Administration Site Adverse Events
Pain
|
497 Participants
|
25 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 (baseline) to Day 7Population: Analysis was performed on the ES. As pre-specified in Protocol, data for this outcome measure were collected only for the Chinese groups (RSV OA vaccine Group \[China\] and Placebo Group \[China\]), from which only those participants with data available for solicited systemic adverse events at the specified time period were reported in this outcome measure.
Assessed solicited systemic adverse events were fever (pyrexia), headache, myalgia (muscle pain), arthralgia (joint pain) and fatigue (tiredness). Fever was defined as body temperature greater or equal to (≥) 38 degrees Celsius (ºC). Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
RSV OA Vaccine Group (China)
n=1193 Participants
Chinese OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6 or last acute respiratory illness (ARI) visit/contact, whichever was later).
|
RSV OA Vaccine Group (Overseas)
n=600 Participants
Overseas OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6).
|
Placebo Group (China)
Chinese OA participants received a single dose of placebo at Day 1 and were followed up until end of study (Month 6 or last ARI visit/contact, whichever was later).
|
|---|---|---|---|
|
Number of Participants Reporting Any Solicited Systemic Adverse Events
Arthralgia
|
67 Participants
|
11 Participants
|
—
|
|
Number of Participants Reporting Any Solicited Systemic Adverse Events
Fatigue
|
162 Participants
|
19 Participants
|
—
|
|
Number of Participants Reporting Any Solicited Systemic Adverse Events
Headache
|
93 Participants
|
14 Participants
|
—
|
|
Number of Participants Reporting Any Solicited Systemic Adverse Events
Myalgia
|
123 Participants
|
12 Participants
|
—
|
|
Number of Participants Reporting Any Solicited Systemic Adverse Events
Fever
|
30 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 (baseline) to Day 30Population: Analysis was performed on the ES. As pre-specified in Protocol, data for this outcome measure was presented only for the Chinese participants (RSV OA vaccine Group \[China\] and Placebo Group \[China\]), from which only those participants with data available for the specified analysis at the specified time period were reported in this outcome measure.
An unsolicited AE was an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs included both serious and non-serious AEs. Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
RSV OA Vaccine Group (China)
n=1199 Participants
Chinese OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6 or last acute respiratory illness (ARI) visit/contact, whichever was later).
|
RSV OA Vaccine Group (Overseas)
n=601 Participants
Overseas OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6).
|
Placebo Group (China)
Chinese OA participants received a single dose of placebo at Day 1 and were followed up until end of study (Month 6 or last ARI visit/contact, whichever was later).
|
|---|---|---|---|
|
Number of Participants Reporting Any Unsolicited Adverse Events (AEs)
|
165 Participants
|
70 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 (baseline) up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)Population: Analysis was performed on the ES. Only those participants with data available for SAEs at the specified time period were reported in this outcome measure.
An SAE is defined as any untoward medical occurrence that results in death, are life threatening, require hospitalization or prolongation of hospitalization or results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is considered or defined as an important medical event, or abnormal pregnancy outcomes. Any SAE = occurrence of the SAE regardless of the intensity grade or relation to study vaccination. Related SAE = SAE assessed by the investigator as related to the study vaccination. Fatal SAE = occurrence of a fatal SAE regardless of relation to study vaccination.
Outcome measures
| Measure |
RSV OA Vaccine Group (China)
n=820 Participants
Chinese OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6 or last acute respiratory illness (ARI) visit/contact, whichever was later).
|
RSV OA Vaccine Group (Overseas)
n=1199 Participants
Overseas OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6).
|
Placebo Group (China)
n=601 Participants
Chinese OA participants received a single dose of placebo at Day 1 and were followed up until end of study (Month 6 or last ARI visit/contact, whichever was later).
|
|---|---|---|---|
|
Number of Participants Reporting Any Serious Adverse Events (SAEs), Related SAEs and Fatal SAEs up to Data Lock Point of Primary Analysis
Any SAEs
|
28 Participants
|
53 Participants
|
38 Participants
|
|
Number of Participants Reporting Any Serious Adverse Events (SAEs), Related SAEs and Fatal SAEs up to Data Lock Point of Primary Analysis
Related SAEs
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Any Serious Adverse Events (SAEs), Related SAEs and Fatal SAEs up to Data Lock Point of Primary Analysis
Fatal SAEs
|
2 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Throughout the study period (up to 6 months post dose [administered at Day 1 (baseline)])Data not available at the time of initial results posting, will be updated at the final results disclosure stage.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 (baseline) up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)Population: Analysis was performed on the ES. Only those participants with data available for pIMDs at the specified time period were reported in this outcome measure.
pIMDs are a subset of Adverse Events of Specific Interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Any pIMDs = occurrence of the pIMDs regardless of the intensity grade or relation to study vaccination. Related pIMDs = pIMDs assessed by the investigator as related to the study vaccination.
Outcome measures
| Measure |
RSV OA Vaccine Group (China)
n=820 Participants
Chinese OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6 or last acute respiratory illness (ARI) visit/contact, whichever was later).
|
RSV OA Vaccine Group (Overseas)
n=1199 Participants
Overseas OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6).
|
Placebo Group (China)
n=601 Participants
Chinese OA participants received a single dose of placebo at Day 1 and were followed up until end of study (Month 6 or last ARI visit/contact, whichever was later).
|
|---|---|---|---|
|
Number of Participants Reporting Any Potential Immune-mediated Disease (pIMDs) and Related pIMDs up to Data Lock Point for Primary Analysis
Any pIMDs
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Any Potential Immune-mediated Disease (pIMDs) and Related pIMDs up to Data Lock Point for Primary Analysis
Related pIMDs
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Throughout the study period (up to 6 months post dose [administered at Day 1 (baseline)])Data not available at the time of initial results posting, will be updated at the final results disclosure stage.
Outcome measures
Outcome data not reported
Adverse Events
RSV OA Vaccine Group (Overseas)
Serious events: 28 serious events
Other events: 2 other events
Deaths: 2 deaths
RSV OA Vaccine Group (China)
Serious events: 53 serious events
Other events: 641 other events
Deaths: 2 deaths
Placebo Group (China)
Serious events: 38 serious events
Other events: 107 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RSV OA Vaccine Group (Overseas)
n=820 participants at risk
Overseas OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6).
|
RSV OA Vaccine Group (China)
n=1199 participants at risk
Chinese OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6 or last acute respiratory illness (ARI) visit/contact, whichever was later).
|
Placebo Group (China)
n=601 participants at risk
Chinese OA participants received a single dose of placebo at Day 1 and were followed up until end of study (Month 6 or last ARI visit/contact, whichever was later).
|
|---|---|---|---|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
2/1199 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Cardiac disorders
Cor pulmonale
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Cardiac disorders
Sinus arrest
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Cardiac disorders
Atrial flutter
|
0.12%
1/820 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Cardiac disorders
Cardiac failure
|
0.12%
1/820 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Cardiac disorders
Hypertensive heart disease
|
0.12%
1/820 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.42%
5/1199 • Number of events 5 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.50%
3/601 • Number of events 4 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
2/1199 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.12%
1/820 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.12%
1/820 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.12%
1/820 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary bullae rupture
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Pneumonia
|
0.24%
2/820 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.25%
3/1199 • Number of events 3 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.67%
4/601 • Number of events 4 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Appendicitis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Septic shock
|
0.12%
1/820 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Erysipelas
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
2/1199 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.33%
2/601 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.12%
1/820 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.12%
1/820 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.12%
1/820 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.12%
1/820 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.12%
1/820 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Gastrointestinal disorders
Intestinal mass
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Gastrointestinal disorders
Salivary gland mass
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.25%
3/1199 • Number of events 3 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
2/1199 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Nervous system disorders
Persistent postural-perceptual dizziness
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Nervous system disorders
Sciatica
|
0.12%
1/820 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Nervous system disorders
Syncope
|
0.12%
1/820 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Nervous system disorders
Facial spasm
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Injury, poisoning and procedural complications
Concussion
|
0.24%
2/820 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.12%
1/820 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.12%
1/820 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.33%
2/601 • Number of events 3 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
2/1199 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
2/1199 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.12%
1/820 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Vascular disorders
Hypertension
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
2/1199 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.33%
2/601 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Vascular disorders
Deep vein thrombosis
|
0.37%
3/820 • Number of events 3 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
2/1199 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Reproductive system and breast disorders
Pelvic organ prolapse
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Reproductive system and breast disorders
Uterine disorder
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Reproductive system and breast disorders
Cystocele
|
0.12%
1/820 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage I
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.12%
1/820 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.12%
1/820 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.12%
1/820 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.12%
1/820 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Metabolism and nutrition disorders
Type 3 diabetes mellitus
|
0.12%
1/820 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Renal and urinary disorders
Renal colic
|
0.12%
1/820 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Renal and urinary disorders
Focal segmental glomerulosclerosis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Hepatobiliary disorders
Acute cholecystitis necrotic
|
0.12%
1/820 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Endocrine disorders
Goitre
|
0.12%
1/820 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Congenital, familial and genetic disorders
Adenomatous polyposis coli
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
Other adverse events
| Measure |
RSV OA Vaccine Group (Overseas)
n=820 participants at risk
Overseas OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6).
|
RSV OA Vaccine Group (China)
n=1199 participants at risk
Chinese OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6 or last acute respiratory illness (ARI) visit/contact, whichever was later).
|
Placebo Group (China)
n=601 participants at risk
Chinese OA participants received a single dose of placebo at Day 1 and were followed up until end of study (Month 6 or last ARI visit/contact, whichever was later).
|
|---|---|---|---|
|
General disorders
Asthenia
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
General disorders
Chills
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
General disorders
Influenza like illness
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
2/1199 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
General disorders
Administration site pain
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
General disorders
Swelling face
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
General disorders
Inflammation
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
General disorders
Vaccination site pruritus
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
General disorders
Vaccination site swelling
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.25%
3/1199 • Number of events 3 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.50%
3/601 • Number of events 3 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
10.4%
125/1199 • Number of events 127 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
2.0%
12/601 • Number of events 12 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
5.8%
69/1199 • Number of events 71 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
1.8%
11/601 • Number of events 11 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.33%
4/1199 • Number of events 5 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
2/1199 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Nervous system disorders
Headache
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
7.9%
95/1199 • Number of events 97 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
2.5%
15/601 • Number of events 15 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.58%
7/1199 • Number of events 8 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
2/1199 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Nervous system disorders
Migraine
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Nervous system disorders
Facial paralysis
|
0.12%
1/820 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
1.6%
19/1199 • Number of events 19 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
1.8%
11/601 • Number of events 11 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.67%
8/1199 • Number of events 8 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.33%
2/601 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.25%
3/1199 • Number of events 3 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.67%
8/1199 • Number of events 8 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.42%
5/1199 • Number of events 5 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.33%
2/601 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.42%
5/1199 • Number of events 5 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.33%
2/601 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Periodontitis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.33%
4/1199 • Number of events 4 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.50%
3/601 • Number of events 3 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.42%
5/1199 • Number of events 5 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
2/1199 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
2/1199 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Skin infection
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
2/1199 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
2/1199 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Urethritis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
2/1199 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Influenza
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Myringitis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Subungual abscess
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
1.0%
12/1199 • Number of events 12 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.33%
2/601 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.67%
8/1199 • Number of events 8 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.50%
3/601 • Number of events 3 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.33%
4/1199 • Number of events 4 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
2/1199 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
2/1199 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
General disorders
Injection site pain
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
41.5%
497/1199 • Number of events 497 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
4.2%
25/601 • Number of events 25 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
General disorders
Fatigue
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
13.7%
164/1199 • Number of events 166 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
3.2%
19/601 • Number of events 19 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
General disorders
Injection site erythema
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
7.3%
88/1199 • Number of events 88 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.50%
3/601 • Number of events 3 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
General disorders
Injection site swelling
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
6.8%
82/1199 • Number of events 82 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
General disorders
Pyrexia
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
4.0%
48/1199 • Number of events 48 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
1.3%
8/601 • Number of events 8 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
General disorders
Chest discomfort
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.25%
3/1199 • Number of events 3 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.25%
3/1199 • Number of events 3 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Gastrointestinal disorders
Dysbiosis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
2/1199 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.33%
2/601 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
2/1199 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.33%
2/601 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Metabolism and nutrition disorders
Gout
|
0.12%
1/820 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 3 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Vascular disorders
Hypertension
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
2/1199 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.33%
2/601 • Number of events 2 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.25%
3/1199 • Number of events 3 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Reproductive system and breast disorders
Uterine mass
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Investigations
Tumour marker increased
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/1199 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.17%
1/601 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Ear and labyrinth disorders
Ear inflammation
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Eye disorders
Dry eye
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/820 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.08%
1/1199 • Number of events 1 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
0.00%
0/601 • Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
|
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