Trial Outcomes & Findings for A Safety Study For Prevenar 13 Among Chinese Children (NCT NCT03656939)
NCT ID: NCT03656939
Last Updated: 2021-08-27
Results Overview
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.
COMPLETED
21240 participants
0 to 3 days after Dose 2
2021-08-27
Participant Flow
This observational study had main study and prospective cohort study. Data for main study and prospective cohort study were observed during 2 years of this observational study.
The main study utilized population-based Yinzhou electronic health record (EHR) database. As part of validation study, prospective cohort study was conducted in sub-population of main study. Main study included eligible children aged 1-24 months who received at least 1 dose of Prevenar 13 recorded in Yinzhou EHR database between 1 May 2017 and 24 July 2020. Prospective cohort study had eligible children for main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020.
Participant milestones
| Measure |
Prevenar 13
Main study cohort included participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Prospective study cohort included eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
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|---|---|
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Overall Study
STARTED
|
21240
|
|
Overall Study
Main Study Cohort
|
21240
|
|
Overall Study
Main Study Cohort: Participants Who Received Dose 1
|
20318
|
|
Overall Study
Main Study Cohort: Participants Who Received Dose 2
|
19387
|
|
Overall Study
Main Study Cohort: Participants Who Received Dose 3
|
18415
|
|
Overall Study
Main Study Cohort: Participants Who Received Dose 4
|
12944
|
|
Overall Study
Prospective Study Cohort
|
2300
|
|
Overall Study
Prospective Study Cohort: Participants Who Received Dose 1
|
2300
|
|
Overall Study
Prospective Study Cohort: Participants Who Received Dose 2
|
2203
|
|
Overall Study
Prospective Study Cohort: Participants Who Received Dose 3
|
2047
|
|
Overall Study
Prospective Study Cohort: Participants Who Received Dose 4
|
1291
|
|
Overall Study
COMPLETED
|
21240
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Prevenar 13
n=21240 Participants
Main study cohort included participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Prospective study cohort included eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
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|---|---|
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Age, Continuous
|
3.15 Months
STANDARD_DEVIATION 1.62 • n=21240 Participants
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Sex: Female, Male
Female
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9944 Participants
n=21240 Participants
|
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Sex: Female, Male
Male
|
11296 Participants
n=21240 Participants
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=81272 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=9200 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
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|---|---|---|
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Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 1
|
NA Events per 1000 person-days
Data was not estimable as no participant had seizure during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=81269 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=9200 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
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|---|---|---|
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Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 1
|
0.025 Events per 1000 person-days
Interval 0.006 to 0.098
|
NA Events per 1000 person-days
Data was not estimable as no participant had seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=162541 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=18400 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 1
|
0.012 Events per 1000 person-days
Interval 0.003 to 0.049
|
NA Events per 1000 person-days
Data was not estimable as no participant had seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=81272 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=9200 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
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|---|---|---|
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Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 1
|
NA Events per 1000 person-days
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=81271 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=9200 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 1
|
0.012 Events per 1000 person-days
Interval 0.002 to 0.087
|
NA Events per 1000 person-days
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=162543 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=18400 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
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Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 1
|
0.006 Events per 1000 person-days
Interval 0.001 to 0.044
|
NA Events per 1000 person-days
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=81269 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=9197 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
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|---|---|---|
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Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1
Urticaria
|
0.012 Events per 1000 person-days
Interval 0.002 to 0.087
|
0.326 Events per 1000 person-days
Interval 0.105 to 1.011
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|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1
Angioedema
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=81267 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=9200 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
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|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1
Urticaria
|
0.025 Events per 1000 person-days
Interval 0.006 to 0.098
|
NA Events per 1000 person-days
Data was not estimable as no participant had urticaria during the specified risk window.
|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1
Angioedema
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=162532 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=18385 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1
Urticaria
|
0.019 Events per 1000 person-days
Interval 0.006 to 0.057
|
0.163 Events per 1000 person-days
Interval 0.053 to 0.506
|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1
Angioedema
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=81272 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=9200 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 1
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=81272 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=9200 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 1
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=162544 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=18400 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 1
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=81137 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=8888 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 1
|
0.555 Events per 1000 person-days
Interval 0.414 to 0.743
|
10.689 Events per 1000 person-days
Interval 8.742 to 13.07
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=81265 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=9195 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 1
|
0.049 Events per 1000 person-days
Interval 0.019 to 0.131
|
0.544 Events per 1000 person-days
Interval 0.226 to 1.307
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=162223 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=17702 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 1
|
0.296 Events per 1000 person-days
Interval 0.223 to 0.393
|
5.649 Events per 1000 person-days
Interval 4.644 to 6.872
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=77548 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=8812 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 2
|
NA Events per 1000 person-days
Data was not estimable as no participant had seizure during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=77548 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=8812 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 2
|
NA Events per 1000 person-days
Data was not estimable as no participant had seizure during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=155096 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=17624 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 2
|
NA Events per 1000 person-days
Data was not estimable as no participant had seizure during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=77548 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=8812 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 2
|
NA Events per 1000 person-days
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=77548 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=8812 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 2
|
NA Events per 1000 person-days
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=155096 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=17624 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 2
|
NA Events per 1000 person-days
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=77536 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=8808 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2
Urticaria
|
0.065 Events per 1000 person-days
Interval 0.027 to 0.155
|
0.227 Events per 1000 person-days
Interval 0.057 to 0.908
|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2
Angioedema
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=77530 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=8812 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2
Urticaria
|
0.129 Events per 1000 person-days
Interval 0.069 to 0.24
|
NA Events per 1000 person-days
Data was not estimable as no participant had urticaria during the specified risk window.
|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2
Angioedema
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=155046 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=17612 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2
Urticaria
|
0.097 Events per 1000 person-days
Interval 0.058 to 0.161
|
0.114 Events per 1000 person-days
Interval 0.028 to 0.454
|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2
Angioedema
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=77548 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=8812 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 2
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=77548 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=8812 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 2
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=155096 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=17624 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 2
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=77439 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=8696 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 2
|
0.517 Events per 1000 person-days
Interval 0.379 to 0.704
|
4.14 Events per 1000 person-days
Interval 2.986 to 5.739
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=77531 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=8808 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 2
|
0.116 Events per 1000 person-days
Interval 0.06 to 0.223
|
0.568 Events per 1000 person-days
Interval 0.236 to 1.364
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=154811 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=17360 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 2
|
0.310 Events per 1000 person-days
Interval 0.234 to 0.411
|
2.362 Events per 1000 person-days
Interval 1.739 to 3.208
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=73660 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=8188 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 3
|
NA Events per 1000 person-days
Data was not estimable as no participant had seizures during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had seizures during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=73660 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=8188 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 3
|
NA Events per 1000 person-days
Data was not estimable as no participant had seizures during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had seizures during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=147320 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=16376 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 3
|
NA Events per 1000 person-days
Data was not estimable as no participant had seizures during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had seizures during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=73660 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=8188 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 3
|
NA Events per 1000 person-days
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=73660 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=8188 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 3
|
NA Events per 1000 person-days
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=147320 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=16376 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 3
|
NA Events per 1000 person-days
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=73657 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=8188 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3
Urticaria
|
0.054 Events per 1000 person-days
Interval 0.02 to 0.145
|
NA Events per 1000 person-days
Data was not estimable as no participant had urticaria during the specified risk window.
|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3
Angioedema
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=73638 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=8188 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3
Urticaria
|
0.136 Events per 1000 person-days
Interval 0.073 to 0.252
|
NA Events per 1000 person-days
Data was not estimable as no participant had urticaria during the specified risk window.
|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3
Angioedema
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=147279 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=16376 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3
Urticaria
|
0.095 Events per 1000 person-days
Interval 0.056 to 0.161
|
NA Events per 1000 person-days
Data was not estimable as no participant had urticaria during the specified risk window.
|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3
Angioedema
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=73660 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=8188 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 3
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=73660 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=8188 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 3
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=147320 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=16376 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 3
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=73601 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=8115 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 3
|
0.367 Events per 1000 person-days
Interval 0.252 to 0.535
|
2.834 Events per 1000 person-days
Interval 1.884 to 4.265
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=73634 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=8180 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 3
|
0.190 Events per 1000 person-days
Interval 0.113 to 0.321
|
0.489 Events per 1000 person-days
Interval 0.184 to 1.303
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=147127 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=16206 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 3
|
0.279 Events per 1000 person-days
Interval 0.205 to 0.379
|
1.604 Events per 1000 person-days
Interval 1.092 to 2.356
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=51766 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=5164 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 4
|
0.058 Events per 1000 person-days
Interval 0.019 to 0.18
|
NA Events per 1000 person-days
Data was not estimable as no participant had seizures during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=51775 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=5164 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 4
|
0.039 Events per 1000 person-days
Interval 0.01 to 0.155
|
NA Events per 1000 person-days
Data was not estimable as no participant had seizures during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=103529 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=10328 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 4
|
0.048 Events per 1000 person-days
Interval 0.02 to 0.116
|
NA Events per 1000 person-days
Data was not estimable as no participant had seizures during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=51776 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=5164 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 4
|
NA Events per 1000 person-days
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=51776 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=5164 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 4
|
0.019 Events per 1000 person-days
Interval 0.003 to 0.137
|
NA Events per 1000 person-days
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=103551 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=10328 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 4
|
0.010 Events per 1000 person-days
Interval 0.001 to 0.069
|
NA Events per 1000 person-days
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=51741 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=5160 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4
Urticaria
|
0.29 Events per 1000 person-days
Interval 0.175 to 0.481
|
0.388 Events per 1000 person-days
Interval 0.097 to 1.55
|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4
Angioedema
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=51727 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=5164 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4
Urticaria
|
0.483 Events per 1000 person-days
Interval 0.327 to 0.715
|
NA Events per 1000 person-days
Data was not estimable as no participant had urticaria during the specified risk window.
|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4
Angioedema
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=103407 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=10316 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4
Urticaria
|
0.387 Events per 1000 person-days
Interval 0.284 to 0.527
|
0.194 Events per 1000 person-days
Interval 0.049 to 0.775
|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4
Angioedema
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=51776 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=5164 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 4
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=51776 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=5164 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 4
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=103552 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=10328 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 4
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=51641 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=4930 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 4
|
1.278 Events per 1000 person-days
Interval 1.004 to 1.627
|
15.822 Events per 1000 person-days
Interval 12.673 to 19.753
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=51622 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=5121 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 4
|
1.298 Events per 1000 person-days
Interval 1.022 to 1.649
|
3.124 Events per 1000 person-days
Interval 1.914 to 5.1
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=103028 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=9749 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 4
|
1.194 Events per 1000 person-days
Interval 1.001 to 1.425
|
9.54 Events per 1000 person-days
Interval 7.785 to 11.69
|
PRIMARY outcome
Timeframe: 0 to 3 Days after all DosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=284246 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=31364 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After All Doses
|
0.011 Events per 1000 person-days
Interval 0.003 to 0.033
|
NA Events per 1000 person-days
Data was not estimable as no participant had seizures during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 Days after all DosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=284252 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=31364 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After All Doses
|
0.014 Events per 1000 person-days
Interval 0.005 to 0.038
|
NA Events per 1000 person-days
Data was not estimable as no participant had seizures during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 Days after all DosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=568486 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=62728 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After All Doses
|
0.012 Events per 1000 person-days
Interval 0.006 to 0.026
|
NA Events per 1000 person-days
Data was not estimable as no participant had seizures during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 Days after all DosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=284256 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=31364 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After All Doses
|
NA Events per 1000 person-days
Data was not estimable as no participant had febrile seizures during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had febrile seizures during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 Days after all DosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=284254 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=31364 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After All Doses
|
0.007 Events per 1000 person-days
Interval 0.002 to 0.028
|
NA Events per 1000 person-days
Data was not estimable as no participant had febrile seizures during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 Days after all DosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=568510 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=62728 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After All Doses
|
0.004 Events per 1000 person-days
Interval 0.001 to 0.014
|
NA Events per 1000 person-days
Data was not estimable as no participant had febrile seizures during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after all DosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=284202 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=31353 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After All Doses
Urticaria
|
0.088 Events per 1000 person-days
Interval 0.059 to 0.13
|
0.223 Events per 1000 person-days
Interval 0.106 to 0.468
|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After All Doses
Angioedema
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after all DosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=284162 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=31364 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After All Doses
Angioedema
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After All Doses
Urticaria
|
0.165 Events per 1000 person-days
Interval 0.124 to 0.22
|
NA Events per 1000 person-days
Data was not estimable as no participant had urticaria during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after all DosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=568263 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=62689 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After All Doses
Urticaria
|
0.127 Events per 1000 person-days
Interval 0.101 to 0.16
|
0.112 Events per 1000 person-days
Interval 0.053 to 0.234
|
|
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After All Doses
Angioedema
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after all dosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=284256 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=31364 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After All Doses
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after all dosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=284256 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=31364 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After All Doses
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after all dosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=568512 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=62728 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After All Doses
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 person-days
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after all dosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=283817 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=30628 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After All Doses
|
0.627 Events per 1000 person-days
Interval 0.542 to 0.726
|
7.575 Events per 1000 person-days
Interval 6.66 to 8.615
|
PRIMARY outcome
Timeframe: 4 to 7 days after all dosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=284051 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=31303 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After All Doses
|
0.331 Events per 1000 person-days
Interval 0.27 to 0.405
|
0.958 Events per 1000 person-days
Interval 0.67 to 1.371
|
PRIMARY outcome
Timeframe: 0 to 7 days after all dosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=567188 Person days at risk
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=61016 Person days at risk
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After All Doses
|
0.458 Events per 1000 person-days
Interval 0.406 to 0.518
|
4.261 Events per 1000 person-days
Interval 3.774 to 4.812
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
IR was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=20318 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2300 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (IR) (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 1
|
NA Events per 1000 doses
Data was not estimable as no participant had seizure during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=20318 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2300 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 1
|
0.098 Events per 1000 doses
Interval 0.025 to 0.394
|
NA Events per 1000 doses
Data was not estimable as no participant had seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=20318 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2300 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 1
|
0.098 Events per 1000 doses
Interval 0.025 to 0.394
|
NA Events per 1000 doses
Data was not estimable as no participant had seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=20318 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2300 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 1
|
NA Events per 1000 doses
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=20318 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2300 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 1
|
0.049 Events per 1000 doses
Interval 0.007 to 0.349
|
NA Events per 1000 doses
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=20318 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2300 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 1
|
0.049 Events per 1000 doses
Interval 0.007 to 0.349
|
NA Events per 1000 doses
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=20318 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2300 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1
Urticaria
|
0.049 Events per 1000 doses
Interval 0.007 to 0.349
|
1.304 Events per 1000 doses
Interval 0.421 to 4.044
|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1
Angioedema
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=20318 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2300 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1
Urticaria
|
0.098 Events per 1000 doses
Interval 0.025 to 0.394
|
NA Events per 1000 doses
Data was not estimable as no participant had urticaria during the specified risk window.
|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1
Angioedema
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=20318 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2300 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1
Urticaria
|
0.148 Events per 1000 doses
Interval 0.048 to 0.458
|
1.304 Events per 1000 doses
Interval 0.421 to 4.044
|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1
Angioedema
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=20318 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2300 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 1
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=20318 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2300 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 1
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=20318 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2300 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 1
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=20318 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2300 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 1
|
2.215 Events per 1000 doses
Interval 1.654 to 2.966
|
41.304 Events per 1000 doses
Interval 33.78 to 50.504
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=20318 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2300 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 1
|
0.197 Events per 1000 doses
Interval 0.074 to 0.525
|
2.174 Events per 1000 doses
Interval 0.905 to 5.223
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 1Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=20318 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2300 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 1
|
2.362 Events per 1000 doses
Interval 1.78 to 3.135
|
43.478 Events per 1000 doses
Interval 35.74 to 52.892
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=19387 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2203 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 2
|
NA Events per 1000 doses
Data was not estimable as no participant had seizure during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=19387 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2203 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 2
|
NA Events per 1000 doses
Data was not estimable as no participant had seizure during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=19387 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2203 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 2
|
NA Events per 1000 doses
Data was not estimable as no participant had seizure during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=19387 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2203 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 2
|
NA Events per 1000 doses
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=19387 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2203 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 2
|
NA Events per 1000 doses
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=19387 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2203 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 2
|
NA Events per 1000 doses
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=19387 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2203 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2
Urticaria
|
0.258 Events per 1000 doses
Interval 0.107 to 0.62
|
0.908 Events per 1000 doses
Interval 0.227 to 3.63
|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2
Angioedema
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=19387 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2203 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2
Urticaria
|
0.516 Events per 1000 doses
Interval 0.278 to 0.959
|
NA Events per 1000 doses
Data was not estimable as no participant had urticaria during the specified risk window.
|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2
Angioedema
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=19387 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2203 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2
Urticaria
|
0.774 Events per 1000 doses
Interval 0.466 to 1.283
|
0.908 Events per 1000 doses
Interval 0.227 to 3.63
|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2
Angioedema
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=19387 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2203 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 2
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=19387 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2203 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 2
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=19387 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2203 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 2
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=19387 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2203 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 2
|
2.063 Events per 1000 doses
Interval 1.513 to 2.813
|
16.341 Events per 1000 doses
Interval 11.788 to 22.655
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=19387 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2203 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 2
|
0.464 Events per 1000 doses
Interval 0.242 to 0.892
|
2.270 Events per 1000 doses
Interval 0.945 to 5.453
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 2Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=19387 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2203 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 2
|
2.476 Events per 1000 doses
Interval 1.866 to 3.285
|
18.611 Events per 1000 doses
Interval 13.704 to 25.276
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=18415 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2047 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 3
|
NA Events per 1000 doses
Data was not estimable as no participant had seizure during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=18415 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2047 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 3
|
NA Events per 1000 doses
Data was not estimable as no participant had seizures during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had seizures during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=18415 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2047 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 3
|
NA Events per 1000 doses
Data was not estimable as no participant had seizure during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=18415 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2047 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 3
|
NA Events per 1000 doses
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=18415 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2047 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 3
|
NA Events per 1000 doses
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=18415 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2047 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 3
|
NA Events per 1000 doses
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=18415 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2047 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3
Urticaria
|
0.217 Events per 1000 doses
Interval 0.082 to 0.579
|
NA Events per 1000 doses
Data was not estimable as no participant had urticaria during the specified risk window.
|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3
Angioedema
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=18415 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2047 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3
Urticaria
|
0.543 Events per 1000 doses
Interval 0.292 to 1.009
|
NA Events per 1000 doses
Data was not estimable as no participant had urticaria during the specified risk window.
|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3
Angioedema
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=18415 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2047 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3
Urticaria
|
0.760 Events per 1000 doses
Interval 0.45 to 1.284
|
NA Events per 1000 doses
Data was not estimable as no participant had urticaria during the specified risk window.
|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3
Angioedema
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=18415 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2047 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 3
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=18415 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2047 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 3
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=18415 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2047 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 3
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=18415 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2047 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 3
|
1.466 Events per 1000 doses
Interval 1.006 to 2.138
|
11.236 Events per 1000 doses
Interval 7.467 to 16.908
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=18415 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2047 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 3
|
0.760 Events per 1000 doses
Interval 0.45 to 1.284
|
1.954 Events per 1000 doses
Interval 0.733 to 5.207
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 3Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=18415 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=2047 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 3
|
2.226 Events per 1000 doses
Interval 1.639 to 3.024
|
12.702 Events per 1000 doses
Interval 8.648 to 18.655
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=12944 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=1291 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 4
|
0.232 Events per 1000 doses
Interval 0.075 to 0.719
|
NA Events per 1000 doses
Data was not estimable as no participant had seizures during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=12944 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=1291 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 4
|
0.155 Events per 1000 doses
Interval 0.039 to 0.618
|
NA Events per 1000 doses
Data was not estimable as no participant had seizures during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=12944 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=1291 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 4
|
0.386 Events per 1000 doses
Interval 0.161 to 0.928
|
NA Events per 1000 doses
Data was not estimable as no participant had seizures during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=12944 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=1291 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 4
|
NA Events per 1000 doses
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=12944 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=1291 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 4
|
0.077 Events per 1000 doses
Interval 0.011 to 0.548
|
NA Events per 1000 doses
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=12944 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=1291 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 4
|
0.077 Events per 1000 doses
Interval 0.011 to 0.548
|
NA Events per 1000 doses
Data was not estimable as no participant had febrile seizure during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=12944 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=1291 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4
Urticaria
|
1.159 Events per 1000 doses
Interval 0.699 to 1.922
|
1.549 Events per 1000 doses
Interval 0.387 to 6.194
|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4
Angioedema
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=12944 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=1291 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4
Urticaria
|
1.931 Events per 1000 doses
Interval 1.305 to 2.858
|
NA Events per 1000 doses
Data was not estimable as no participant had urticaria during the specified risk window.
|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4
Angioedema
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=12944 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=1291 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4
Urticaria
|
3.090 Events per 1000 doses
Interval 2.267 to 4.213
|
1.549 Events per 1000 doses
Interval 0.387 to 6.194
|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4
Angioedema
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=12944 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=1291 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 4
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=12944 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=1291 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 4
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=12944 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=1291 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 4
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=12944 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=1291 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 4
|
5.099 Events per 1000 doses
Interval 4.006 to 6.49
|
60.418 Events per 1000 doses
Interval 48.394 to 75.431
|
PRIMARY outcome
Timeframe: 4 to 7 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=12944 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=1291 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 4
|
5.176 Events per 1000 doses
Interval 4.074 to 6.577
|
12.394 Events per 1000 doses
Interval 7.593 to 20.23
|
PRIMARY outcome
Timeframe: 0 to 7 days after Dose 4Population: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=12944 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=1291 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 4
|
9.503 Events per 1000 doses
Interval 7.963 to 11.339
|
72.037 Events per 1000 doses
Interval 58.788 to 88.272
|
PRIMARY outcome
Timeframe: 0 to 3 days after all dosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=71064 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=7841 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After All Doses
|
0.042 Events per 1000 doses
Interval 0.014 to 0.131
|
NA Events per 1000 doses
Data was not estimable as no participant had seizures during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after all dosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=71064 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=7841 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After All Doses
|
0.056 Events per 1000 doses
Interval 0.021 to 0.15
|
NA Events per 1000 doses
Data was not estimable as no participant had seizures during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after all dosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=71064 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=7841 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After All Doses
|
0.099 Events per 1000 doses
Interval 0.047 to 0.207
|
NA Events per 1000 doses
Data was not estimable as no participant had seizures during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after all dosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=71064 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=7841 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After All Doses
|
NA Events per 1000 doses
Data was not estimable as no participant had febrile seizures during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had febrile seizures during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after all dosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=71064 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=7841 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After All Doses
|
0.028 Events per 1000 doses
Interval 0.007 to 0.113
|
NA Events per 1000 doses
Data was not estimable as no participant had febrile seizures during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after all dosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=71064 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=7841 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After All Doses
|
0.028 Events per 1000 doses
Interval 0.007 to 0.113
|
NA Events per 1000 doses
Data was not estimable as no participant had febrile seizures during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after all DosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=71064 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=7841 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After All Doses
Urticaria
|
0.352 Events per 1000 doses
Interval 0.238 to 0.521
|
0.893 Events per 1000 doses
Interval 0.426 to 1.873
|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After All Doses
Angioedema
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after all DosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=71064 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=7841 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After All Doses
Urticaria
|
0.661 Events per 1000 doses
Interval 0.497 to 0.88
|
NA Events per 1000 doses
Data was not estimable as no participant had urticaria during the specified risk window.
|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After All Doses
Angioedema
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after all DosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=71064 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=7841 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After All Doses
Urticaria
|
1.013 Events per 1000 doses
Interval 0.804 to 1.276
|
0.893 Events per 1000 doses
Interval 0.426 to 1.873
|
|
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After All Doses
Angioedema
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had angioedema during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after all DosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=71064 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=7841 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After All Doses
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 4 to 7 days after all DosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=71064 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=7841 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After All Doses
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 7 days after all DosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=71064 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=7841 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After All Doses
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
NA Events per 1000 doses
Data was not estimable as no participant had apnea during the specified risk window.
|
PRIMARY outcome
Timeframe: 0 to 3 days after all dosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=20318 Participants
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=7841 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After All Doses
|
2.505 Events per 1000 doses
Interval 2.163 to 2.901
|
29.588 Events per 1000 doses
Interval 26.016 to 33.651
|
PRIMARY outcome
Timeframe: 4 to 7 days after all dosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=71064 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=7841 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After All Doses
|
1.323 Events per 1000 doses
Interval 1.081 to 1.619
|
3.826 Events per 1000 doses
Interval 2.675 to 5.472
|
PRIMARY outcome
Timeframe: 0 to 7 days after all dosesPopulation: Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.
Outcome measures
| Measure |
Prevenar 13: Main Study Cohort
n=71064 Doses
Participants aged 1 to 24 months who received at least 1 dose of Prevenar 13 between 1 May 2017 and 24 July 2020 in the Yinzhou database were observed in the study. First dose of Prevenar 13 was received on or before 24 July 2020. Participants were followed up to 7 days after each dose of Prevenar 13.
|
Prevenar 13 Cohort: Prospective Cohort Study
n=7841 Doses
In this cohort, eligible participants of the main study who received first dose of Prevenar 13 between 1 August 2018 and 24 July 2020 in the Yinzhou EHR database were observed. Participants were followed up to 7 days after each dose of Prevenar 13.
|
|---|---|---|
|
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After All Doses
|
3.659 Events per 1000 doses
Interval 3.24 to 4.132
|
33.159 Events per 1000 doses
Interval 29.364 to 37.445
|
Adverse Events
Prevenar 13: Main Study Cohort
Prevenar 13 Cohort: Prospective Cohort Study
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER