Trial Outcomes & Findings for ZOSTAVAX™ Safety Study in Subjects ≥ 60 Years of Age (V211-020) (NCT NCT00550745)
NCT ID: NCT00550745
Last Updated: 2017-04-12
Results Overview
Only Serious Adverse Events were collected and analyzed for this study. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
11999 participants
Primary outcome timeframe
42 Days
Results posted on
2017-04-12
Participant Flow
Phase IV First subject enrolled on 17-Sep-2007. Last subject enrolled on 19-Jun-2008. The last subject's last visit was 15-Jan-2009. The study was conducted at 46 study centers throughout the United States, Canada, Germany, Spain, and United Kingdom.
Participant milestones
| Measure |
ZOSTAVAX™
Represents the number of randomized subjects according to the vaccination group as they were assigned at study entry and not the treatment, ZOSTAVAX™ or placebo, received.
|
Placebo
Represents the number of randomized subjects according to the vaccination group as they were assigned at study entry and not the treatment, ZOSTAVAX™ or placebo, received.
|
|---|---|---|
|
Overall Study
STARTED
|
6000
|
5999
|
|
Overall Study
COMPLETED
|
5913
|
5939
|
|
Overall Study
NOT COMPLETED
|
87
|
60
|
Reasons for withdrawal
| Measure |
ZOSTAVAX™
Represents the number of randomized subjects according to the vaccination group as they were assigned at study entry and not the treatment, ZOSTAVAX™ or placebo, received.
|
Placebo
Represents the number of randomized subjects according to the vaccination group as they were assigned at study entry and not the treatment, ZOSTAVAX™ or placebo, received.
|
|---|---|---|
|
Overall Study
Death
|
20
|
16
|
|
Overall Study
Lost to Follow-up
|
45
|
30
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Protocol Violation
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
17
|
10
|
|
Overall Study
Screen failure
|
1
|
0
|
Baseline Characteristics
ZOSTAVAX™ Safety Study in Subjects ≥ 60 Years of Age (V211-020)
Baseline characteristics by cohort
| Measure |
ZOSTAVAX™
n=5983 Participants
Represents the number of subjects according to the treatment (ZOSTAVAX™) received.
Excludes subjects who were not vaccinated.
|
Placebo
n=5997 Participants
Represents the number of subjects according to the treatment (placebo) received.
Excludes subjects who were not vaccinated.
|
Total
n=11980 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.5 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
70.4 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
70.5 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Age, Customized
60 to 69 Years of Age
|
3092 participants
n=5 Participants
|
3113 participants
n=7 Participants
|
6205 participants
n=5 Participants
|
|
Age, Customized
70 to 79 Years of Age
|
1994 participants
n=5 Participants
|
1986 participants
n=7 Participants
|
3980 participants
n=5 Participants
|
|
Age, Customized
≥ 80 Years of Age
|
897 participants
n=5 Participants
|
898 participants
n=7 Participants
|
1795 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3515 Participants
n=5 Participants
|
3525 Participants
n=7 Participants
|
7040 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2468 Participants
n=5 Participants
|
2472 Participants
n=7 Participants
|
4940 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
109 participants
n=5 Participants
|
85 participants
n=7 Participants
|
194 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
5759 participants
n=5 Participants
|
5770 participants
n=7 Participants
|
11529 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
115 participants
n=5 Participants
|
142 participants
n=7 Participants
|
257 participants
n=5 Participants
|
|
Region
U.S.
|
5309 Participants
n=5 Participants
|
5312 Participants
n=7 Participants
|
10621 Participants
n=5 Participants
|
|
Region
Non-U.S.
|
674 Participants
n=5 Participants
|
685 Participants
n=7 Participants
|
1359 Participants
n=5 Participants
|
|
Type of Residence
Assisted Living
|
176 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
338 Participants
n=5 Participants
|
|
Type of Residence
Independent Residential
|
5790 Participants
n=5 Participants
|
5821 Participants
n=7 Participants
|
11611 Participants
n=5 Participants
|
|
Type of Residence
Nursing Home
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 42 DaysPopulation: All subjects who were vaccinated according to actual treatment received (ZOSTAVAX™ or placebo) and had safety follow-up. Death - Number of subjects that had a fatal serious adverse event with an onset date within the 42 day reporting period. The date of death may have occurred after 42 days.
Only Serious Adverse Events were collected and analyzed for this study. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement.
Outcome measures
| Measure |
ZOSTAVAX™
n=5979 Participants
All subjects who were vaccinated according to actual treatment received (ZOSTAVAX™) and had safety follow-up.
|
Placebo
n=5990 Participants
All subjects who were vaccinated according to actual treatment received (Placebo) and had safety follow-up.
|
|---|---|---|
|
Serious Adverse Events Reported Within 42 Days Postvaccination
Serious Adverse Events (AEs)
|
84 Participants
|
67 Participants
|
|
Serious Adverse Events Reported Within 42 Days Postvaccination
Serious AEs deemed vaccine-related by investigator
|
2 Participants
|
0 Participants
|
|
Serious Adverse Events Reported Within 42 Days Postvaccination
Death
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All subjects who were vaccinated according to actual treatment received (ZOSTAVAX™ or placebo) and had safety follow-up. Death - Number of subjects that had a fatal serious adverse event with an onset date within the 182 day reporting period. The date of death may have occurred after 182 days.
Only Serious Adverse Events were collected and analyzed for this study. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement.
Outcome measures
| Measure |
ZOSTAVAX™
n=5979 Participants
All subjects who were vaccinated according to actual treatment received (ZOSTAVAX™) and had safety follow-up.
|
Placebo
n=5990 Participants
All subjects who were vaccinated according to actual treatment received (Placebo) and had safety follow-up.
|
|---|---|---|
|
Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination
Serious AEs
|
340 Participants
|
300 Participants
|
|
Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination
Serious AEs deemed vaccine-related by investigator
|
2 Participants
|
1 Participants
|
|
Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination
Death
|
24 Participants
|
17 Participants
|
Adverse Events
ZOSTAVAX™
Serious events: 340 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 300 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ZOSTAVAX™
n=5979 participants at risk
All subjects who were vaccinated according to actual treatment received (Zostavax™) and had safety follow-up.
|
Placebo
n=5990 participants at risk
All subjects who were vaccinated according to actual treatment received (Placebo) and had safety follow-up.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.07%
4/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Blood and lymphatic system disorders
Macrocytosis
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.07%
4/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.05%
3/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.05%
3/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Angina unstable
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Atrial fibrillation
|
0.35%
21/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.23%
14/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Atrial flutter
|
0.08%
5/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Atrioventricular block
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Bradycardia
|
0.10%
6/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Cardiac arrest
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Cardiac disorder
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Cardiac failure
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.13%
8/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.15%
9/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Cardiogenic shock
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Conduction disorder
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Coronary artery disease
|
0.18%
11/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.25%
15/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Coronary artery restenosis
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Mitral valve prolapse
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Myocardial infarction
|
0.13%
8/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.23%
14/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Pericardial effusion
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Sinus tachycardia
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Ventricular hypertrophy
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Cardiac disorders
Wandering pacemaker
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Endocrine disorders
Goitre
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Endocrine disorders
Hyperaldosteronism
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Eye disorders
Retinal detachment
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Eye disorders
Uveitis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Abdominal mass
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Appendicitis perforated
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Colitis
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Constipation
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Diverticulum
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.12%
7/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Ileus
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.07%
4/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.07%
4/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.05%
3/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.05%
3/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
General disorders
Adhesion
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
General disorders
Catheter related complication
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
General disorders
Chest discomfort
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
General disorders
Chest pain
|
0.20%
12/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.28%
17/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
General disorders
Death
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
General disorders
Hernia obstructive
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
General disorders
Multi-organ failure
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
General disorders
Non-cardiac chest pain
|
0.08%
5/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
General disorders
Oedema peripheral
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
General disorders
Pyrexia
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Hepatobiliary disorders
Biliary colic
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Hepatobiliary disorders
Cholangitis
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Immune system disorders
Anaphylactic reaction
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Abdominal abscess
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Abdominal wall abscess
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Abscess
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Appendicitis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Bacteraemia
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Bacterial infection
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Bone abscess
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Bronchiectasis
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Bronchitis
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.05%
3/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Cellulitis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.13%
8/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Cholecystitis infective
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Clostridial infection
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Device related infection
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Diverticulitis
|
0.13%
8/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.07%
4/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Empyema
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Enterococcal infection
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Eye infection
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Gastroenteritis
|
0.08%
5/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Gastroenteritis viral
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.05%
3/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Lemierre syndrome
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Lobar pneumonia
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.05%
3/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Meningitis
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Meningitis aseptic
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Necrotising fasciitis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Pleural infection
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Pneumonia
|
0.27%
16/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.22%
13/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Post procedural infection
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Postoperative wound infection
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Pyelonephritis
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Pyelonephritis acute
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Pyothorax
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Respiratory tract infection
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Sepsis
|
0.10%
6/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Septic phlebitis
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Septic shock
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Sinusitis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Soft tissue infection
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Urinary tract infection
|
0.10%
6/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.05%
3/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Urosepsis
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Infections and infestations
Viral infection
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Anastomotic complication
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Dislocation of joint prosthesis
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Eyeball rupture
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Fall
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Foreign body trauma
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Gastrointestinal injury
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.05%
3/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Implantable defibrillator malfunction
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
In-stent coronary artery restenosis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.08%
5/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Thrombosis in device
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Tracheal injury
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Investigations
Blood glucose increased
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.05%
3/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.07%
4/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.05%
3/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.08%
5/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthrofibrosis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.07%
4/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.23%
14/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.17%
10/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.20%
12/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.12%
7/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.08%
5/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.12%
7/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac myxoma
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gammopathy
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease stage IV
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma recurrent
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis fungoides
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloma recurrence
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurilemmoma benign
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian low malignant potential tumour
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritoneal carcinoma
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.07%
4/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.10%
6/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.23%
14/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.13%
8/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Nervous system disorders
Carotid artery disease
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.10%
6/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Nervous system disorders
Convulsion
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Nervous system disorders
Dementia
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Nervous system disorders
Embolic stroke
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Nervous system disorders
Global amnesia
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Nervous system disorders
Lacunar infarction
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Nervous system disorders
Myoclonus
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Nervous system disorders
Presyncope
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Nervous system disorders
Radiculopathy
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Nervous system disorders
Sciatica
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Nervous system disorders
Syncope
|
0.17%
10/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.08%
5/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Nervous system disorders
Syncope vasovagal
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.10%
6/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Psychiatric disorders
Affective disorder
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Psychiatric disorders
Bipolar I disorder
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Psychiatric disorders
Catatonia
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Psychiatric disorders
Confusional state
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Psychiatric disorders
Depression
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Psychiatric disorders
Dissociative identity disorder
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Psychiatric disorders
Major depression
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Renal and urinary disorders
Hypotonic urinary bladder
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Renal and urinary disorders
Renal failure
|
0.05%
3/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Renal and urinary disorders
Renal failure acute
|
0.20%
12/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Renal and urinary disorders
Urinary retention
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Reproductive system and breast disorders
Epididymitis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.13%
8/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.18%
11/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.08%
5/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.05%
3/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Surgical and medical procedures
Thyroidectomy
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Vascular disorders
Aortic aneurysm
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Vascular disorders
Aortic stenosis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Vascular disorders
Arterial occlusive disease
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Vascular disorders
Arteriosclerosis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Vascular disorders
Deep vein thrombosis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Vascular disorders
Femoral arterial stenosis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Vascular disorders
Femoral artery aneurysm
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Vascular disorders
Haematoma
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Vascular disorders
Hypertension
|
0.05%
3/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.03%
2/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Vascular disorders
Hypotension
|
0.05%
3/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Vascular disorders
Temporal arteritis
|
0.03%
2/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Vascular disorders
Vasculitis
|
0.02%
1/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.00%
0/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/5979 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
0.02%
1/5990 • Serious AEs reported within 6 months (182 days) postvaccination. Only Serious adverse events were collected in this study. The "Other Adverse Events" table is not applicable for this study and shows "0/0" for " participants affected/at risk"
Subjects were instructed to call the site immediately, at any time during the study, if they experienced a serious adverse event. Subjects were also called by study staff at 42 days, 4 months, and 6 months postvaccination, using a prespecified phone script, to determine if subjects had a previously unreported serious adverse event.
|
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck 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