A Safety Study For Prevenar 13 Among Chinese Children | NCT03656939 | Trialant
NCT03656939
Sponsor
Pfizer
Status
Completed
Last Update Posted
Aug 27, 2021Actual
Enrollment
21,240Actual
Phase
Not provided
Conditions
Seizures
Urticaria and Angioedema
Apnea
Fever
Interventions
Not provided
Countries
China
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT03656939
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
B1851193
Secondary IDs
Not provided
Brief Title
A Safety Study For Prevenar 13 Among Chinese Children
Official Title
AN OBSERVATIONAL SAFETY STUDY FOR PREVENAR 13 AMONG CHINESE CHILDREN
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Jul 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 1, 2018Actual
Primary Completion Date
Jul 31, 2020Actual
Completion Date
Jul 31, 2020Actual
First Submitted Date
Jul 20, 2018
First Submission Date that Met QC Criteria
Aug 30, 2018
First Posted Date
Sep 4, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Jul 30, 2021
Results First Submitted that Met QC Criteria
Jul 30, 2021
Results First Posted Date
Aug 27, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 30, 2021
Last Update Posted Date
Aug 27, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is an observational study based on a population-based EHR database.
Detailed Description
This observational study based on a population-based EHR database in Yinzhou district of Ningbo city in China is to estimate incidence rates of seizures (including febrile seizures), urticaria and angioedema, apnea, and fever among Chinese children after receiving Prevenar 13. In addition, a validation study including validation of International classification of diseases, tenth revision (ICD-10) codes or ICD-10 code based algorithm for identifying all safety outcomes of interest and a prospective cohort study in a sub-population of the main study will be conducted in order to offset the potential biased results from the main study because of potential misclassification of the safety outcomes of interest due to miscoding and/or undercoding of ICD-10 codes used to identify these safety outcomes in the EHR database.
Conditions Module
Conditions
Seizures
Urticaria and Angioedema
Apnea
Fever
Keywords
Not provided
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
No
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
21,240Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Prevenar 13 cohort
This is a non-interventional study. Children in the study receive Prevenar 13 per normal medical practice.
Interventions
Not provided
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 1
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.
0 to 3 days after Dose 1
Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 1
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.
4 to 7 days after Dose 1
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 1
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.
0 to 7 days after Dose 1
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 1
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.
0 to 3 days after Dose 1
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 1
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.
4 to 7 days after Dose 1
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 1
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
To be eligible for the main study, children in Yinzhou population-based EHR database must be aged 1 to 24 months and receive at least one dose of 13vPnC between May 1st, 2017 and July 24th, 2020 where the first dose is received before or on July 24th, 2020 since a 7-day post-vaccination follow-up for each dose in each child receiving 13vPnC is needed. For the prospective cohort in a sub-population of the main study, eligible children for the main study must receive the first dose of 13vPnC between August 1st, 2018 and July 24th, 2020 and an informed consent must be obtained from parents/legal guardians.
Exclusion Criteria:
There are no exclusion criteria for this study.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
1 Month
Maximum Age
24 Months
Standard Ages
Child
Study Population
The main study population consists of eligible children aged 1-24 months receiving at least one dose of 13vPnC recorded in Yinzhou EHR database between May 1st, 2017 and July 24th, 2020 (ie, one week prior to the end of the study).
For the prospective cohort in a sub-population of the main study, eligible children for the main study must receive the first dose of 13vPnC between August 1st, 2018 and July 24th, 2020. It should be noted that the actual start date for the prospective cohort study is pending on the approval of Human Genetic Resources Administration of China (HGRAC) application.
Sampling Method
Non-Probability Sample
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
School of Public Health at Fudan University
Shanghai
200032
China
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
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.
Recruitment Details
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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00021240 subjects
Main Study Cohort
FG00021240 subjects
Main Study Cohort: Participants Who Received Dose 1
FG00020318 subjects
Main Study Cohort: Participants Who Received Dose 2
FG00019387 subjects
Main Study Cohort: Participants Who Received Dose 3
FG00018415 subjects
Main Study Cohort: Participants Who Received Dose 4
FG00012944 subjects
Prospective Study Cohort
FG0002300 subjects
Prospective Study Cohort: Participants Who Received Dose 1
FG0002300 subjects
Prospective Study Cohort: Participants Who Received Dose 2
FG0002203 subjects
Prospective Study Cohort: Participants Who Received Dose 3
FG0002047 subjects
Prospective Study Cohort: Participants Who Received Dose 4
FG0001291 subjects
COMPLETED
FG00021240 subjects
NOT COMPLETED
FG0000 subjects
Baseline Characteristics Module
Baseline Analysis Population Description
Analysis was performed on the main study population which consisted of 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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 3 days after Dose 1
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
Adverse Events Module
Frequency Threshold
0
Time Frame
Not applicable as adverse events were not collected for the study
Description
Due to the nature of claims database from which data were queried, the minimum criteria for reporting an adverse event (i.e., identifiable participant, identifiable reporter, a suspect product, and event) could not meet, hence adverse events were not collected and reported.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Prevenar 13: Main Study Cohort
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.
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.
0 to 7 days after Dose 1
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1
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.
0 to 3 days after Dose 1
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1
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.
4 to 7 days after Dose 1
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1
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.
0 to 7 days after Dose 1
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 1
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.
0 to 3 days after Dose 1
Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 1
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.
4 to 7 days after Dose 1
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 1
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.
0 to 7 days after Dose 1
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 1
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.
0 to 3 days after Dose 1
Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 1
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.
4 to 7 days after Dose 1
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 1
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.
0 to 7 days after Dose 1
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 2
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.
0 to 3 days after Dose 2
Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 2
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.
4 to 7 days after Dose 2
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 2
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.
0 to 7 days after Dose 2
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 2
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.
0 to 3 days after Dose 2
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 2
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.
4 to 7 days after Dose 2
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 2
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.
0 to 7 days after Dose 2
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2
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.
0 to 3 days after Dose 2
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2
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.
4 to 7 days after Dose 2
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2
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.
0 to 7 days after Dose 2
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 2
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.
0 to 3 days after Dose 2
Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 2
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.
4 to 7 days after Dose 2
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 2
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.
0 to 7 days after Dose 2
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 2
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.
0 to 3 days after Dose 2
Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 2
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.
4 to 7 days after Dose 2
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 2
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.
0 to 7 days after Dose 2
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 3
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.
0 to 3 days after Dose 3
Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 3
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.
4 to 7 days after Dose 3
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 3
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.
0 to 7 days after Dose 3
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 3
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.
0 to 3 days after Dose 3
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 3
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.
4 to 7 days after Dose 3
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 3
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.
0 to 7 days after Dose 3
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3
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.
0 to 3 days after Dose 3
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3
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.
4 to 7 days after Dose 3
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3
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.
0 to 7 days after Dose 3
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 3
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.
0 to 3 days after Dose 3
Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 3
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.
4 to 7 days after Dose 3
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 3
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.
0 to 7 days after Dose 3
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 3
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.
0 to 3 days after Dose 3
Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 3
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.
4 to 7 days after Dose 3
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 3
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.
0 to 7 days after Dose 3
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 4
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.
0 to 3 days after Dose 4
Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 4
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.
4 to 7 days after Dose 4
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 4
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.
0 to 7 days after Dose 4
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 4
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.
0 to 3 days after Dose 4
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 4
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.
4 to 7 days after Dose 4
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 4
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.
0 to 7 days after Dose 4
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4
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.
0 to 3 days after Dose 4
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4
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.
4 to 7 days after Dose 4
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4
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.
0 to 7 days after Dose 4
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 4
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.
0 to 3 days after Dose 4
Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 4
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.
4 to 7 days after Dose 4
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 4
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.
0 to 7 days after Dose 4
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 4
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.
0 to 3 days after Dose 4
Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 4
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.
4 to 7 days after Dose 4
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 4
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.
0 to 7 days after Dose 4
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After All Doses
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.
0 to 3 Days after all Doses
Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After All Doses
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.
4 to 7 Days after all Doses
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After All Doses
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.
0 to 7 Days after all Doses
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After All Doses
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.
0 to 3 Days after all Doses
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After All Doses
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.
4 to 7 Days after all Doses
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After All Doses
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.
0 to 7 Days after all Doses
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After All Doses
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.
0 to 3 days after all Doses
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After All Doses
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.
4 to 7 days after all Doses
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After All Doses
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.
0 to 7 days after all Doses
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After All Doses
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.
0 to 3 days after all doses
Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After All Doses
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.
4 to 7 days after all doses
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After All Doses
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.
0 to 7 days after all doses
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After All Doses
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.
0 to 3 days after all doses
Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After All Doses
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.
4 to 7 days after all doses
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After All Doses
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.
0 to 7 days after all doses
Incidence Rate (IR) (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 1
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.
0 to 3 days after Dose 1
Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 1
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.
4 to 7 days after Dose 1
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 1
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.
0 to 7 days after Dose 1
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 1
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.
0 to 3 days after Dose 1
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 1
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.
4 to 7 days after Dose 1
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 1
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.
0 to 7 days after Dose 1
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1
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.
0 to 3 days after Dose 1
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1
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.
4 to 7 days after Dose 1
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1
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.
0 to 7 days after Dose 1
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 1
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.
0 to 3 days after Dose 1
Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 1
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.
4 to 7 days after Dose 1
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 1
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.
0 to 7 days after Dose 1
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 1
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.
0 to 3 days after Dose 1
Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 1
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.
4 to 7 days after Dose 1
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 1
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.
0 to 7 days after Dose 1
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 2
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.
0 to 3 days after Dose 2
Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 2
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.
4 to 7 days after Dose 2
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 2
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.
0 to 7 days after Dose 2
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 2
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.
0 to 3 days after Dose 2
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 2
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.
4 to 7 days after Dose 2
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 2
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.
0 to 7 days after Dose 2
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2
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.
0 to 3 days after Dose 2
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2
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.
4 to 7 days after Dose 2
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2
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.
0 to 7 days after Dose 2
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 2
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.
0 to 3 days after Dose 2
Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 2
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.
4 to 7 days after Dose 2
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 2
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.
0 to 7 days after Dose 2
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 2
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.
0 to 3 days after Dose 2
Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 2
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.
4 to 7 days after Dose 2
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 2
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.
0 to 7 days after Dose 2
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 3
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.
0 to 3 days after Dose 3
Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 3
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.
4 to 7 days after Dose 3
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 3
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.
0 to 7 days after Dose 3
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 3
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.
0 to 3 days after Dose 3
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 3
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.
4 to 7 days after Dose 3
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 3
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.
0 to 7 days after Dose 3
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3
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.
0 to 3 days after Dose 3
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3
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.
4 to 7 days after Dose 3
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3
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.
0 to 7 days after Dose 3
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 3
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.
0 to 3 days after Dose 3
Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 3
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.
4 to 7 days after Dose 3
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 3
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.
0 to 7 days after Dose 3
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 3
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.
0 to 3 days after Dose 3
Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 3
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.
4 to 7 days after Dose 3
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 3
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.
0 to 7 days after Dose 3
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 4
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.
0 to 3 days after Dose 4
Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 4
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.
4 to 7 days after Dose 4
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 4
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.
0 to 7 days after Dose 4
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 4
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.
0 to 3 days after Dose 4
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 4
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.
4 to 7 days after Dose 4
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 4
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.
0 to 7 days after Dose 4
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4
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.
0 to 3 days after Dose 4
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4
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.
4 to 7 days after Dose 4
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4
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.
0 to 7 days after Dose 4
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 4
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.
0 to 3 days after Dose 4
Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 4
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.
4 to 7 days after Dose 4
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 4
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.
0 to 7 days after Dose 4
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 4
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.
0 to 3 days after Dose 4
Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 4
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.
4 to 7 days after Dose 4
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 4
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.
0 to 7 days after Dose 4
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After All Doses
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.
0 to 3 days after all doses
Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After All Doses
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.
4 to 7 days after all doses
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After All Doses
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.
0 to 7 days after all doses
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After All Doses
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.
0 to 3 days after all doses
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After All Doses
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.
4 to 7 days after all doses
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After All Doses
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.
0 to 7 days after all doses
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After All Doses
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.
0 to 3 days after all Doses
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After All Doses
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.
4 to 7 days after all Doses
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After All Doses
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.
0 to 7 days after all Doses
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After All Doses
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.
0 to 3 days after all Doses
Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After All Doses
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.
4 to 7 days after all Doses
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After All Doses
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.
0 to 7 days after all Doses
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After All Doses
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.
0 to 3 days after all doses
Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After All Doses
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.
4 to 7 days after all doses
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After All Doses
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.
0 to 7 days after all doses
21240
Standard Deviation
Months
Title
Denominators
Categories
ParticipantsBG00021240
Title
Measurements
BG0003.15± 1.62
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00021240
Title
Measurements
Female
BG0009944
Male
BG00011296
Race and Ethnicity Not Collected
Race and Ethnicity were not collected from any participant.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0000
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG00081272
OG0019200
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had seizure during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
4 to 7 days after Dose 1
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG00081269
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.025(0.006 to 0.098)
OG001NA(NA to NA)Data was not estimable as no participant had seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 7 days after Dose 1
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG000162541
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.012(0.003 to 0.049)
OG001NA(NA to NA)Data was not estimable as no participant had seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 3 days after Dose 1
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG00081272
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
4 to 7 days after Dose 1
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG00081271
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.012(0.002 to 0.087)
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 7 days after Dose 1
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG000162543
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.006(0.001 to 0.044)
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 3 days after Dose 1
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG00081269
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0000.012(0.002 to 0.087)
OG0010.326(0.105 to 1.011)
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
4 to 7 days after Dose 1
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG00081267
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0000.025(0.006 to 0.098)
OG001NA(NA to NA)Data was not estimable as no participant had urticaria during the specified risk window.
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 7 days after Dose 1
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG000162532
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0000.019(0.006 to 0.057)
OG0010.163(0.053 to 0.506)
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 3 days after Dose 1
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG00081272
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
4 to 7 days after Dose 1
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG00081272
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 7 days after Dose 1
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG000162544
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 3 days after Dose 1
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG00081137
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.555(0.414 to 0.743)
OG00110.689(8.742 to 13.07)
Primary
Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
4 to 7 days after Dose 1
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG00081265
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.049(0.019 to 0.131)
OG0010.544(0.226 to 1.307)
Primary
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 7 days after Dose 1
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG000162223
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.296(0.223 to 0.393)
OG0015.649(4.644 to 6.872)
Primary
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 3 days after Dose 2
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Person days at risk
OG00077548
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had seizure during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
4 to 7 days after Dose 2
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Person days at risk
OG00077548
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had seizure during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 7 days after Dose 2
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Person days at risk
OG000155096
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had seizure during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 3 days after Dose 2
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Person days at risk
OG00077548
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
4 to 7 days after Dose 2
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Person days at risk
OG00077548
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 7 days after Dose 2
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Person days at risk
OG000155096
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 3 days after Dose 2
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Person days at risk
OG00077536
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0000.065(0.027 to 0.155)
OG0010.227(0.057 to 0.908)
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
4 to 7 days after Dose 2
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Person days at risk
OG00077530
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0000.129(0.069 to 0.240)
OG001NA(NA to NA)Data was not estimable as no participant had urticaria during the specified risk window.
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 7 days after Dose 2
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Person days at risk
OG000155046
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0000.097(0.058 to 0.161)
OG0010.114(0.028 to 0.454)
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 3 days after Dose 2
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Person days at risk
OG00077548
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
4 to 7 days after Dose 2
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Person days at risk
OG00077548
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 7 days after Dose 2
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Person days at risk
OG000155096
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 3 days after Dose 2
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Person days at risk
OG00077439
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.517(0.379 to 0.704)
OG0014.14(2.986 to 5.739)
Primary
Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
4 to 7 days after Dose 2
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Person days at risk
OG00077531
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.116(0.060 to 0.223)
OG0010.568(0.236 to 1.364)
Primary
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 7 days after Dose 2
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Person days at risk
OG000154811
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.310(0.234 to 0.411)
OG0012.362(1.739 to 3.208)
Primary
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 3 days after Dose 3
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Person days at risk
OG00073660
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had seizures during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had seizures during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
4 to 7 days after Dose 3
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Person days at risk
OG00073660
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had seizures during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had seizures during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 7 days after Dose 3
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Person days at risk
OG000147320
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had seizures during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had seizures during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 3 days after Dose 3
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Person days at risk
OG00073660
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
4 to 7 days after Dose 3
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Person days at risk
OG00073660
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 7 days after Dose 3
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Person days at risk
OG000147320
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 3 days after Dose 3
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Person days at risk
OG00073657
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0000.054(0.020 to 0.145)
OG001NA(NA to NA)Data was not estimable as no participant had urticaria during the specified risk window.
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
4 to 7 days after Dose 3
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Person days at risk
OG00073638
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0000.136(0.073 to 0.252)
OG001NA(NA to NA)Data was not estimable as no participant had urticaria during the specified risk window.
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 7 days after Dose 3
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Person days at risk
OG000147279
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0000.095(0.056 to 0.161)
OG001NA(NA to NA)Data was not estimable as no participant had urticaria during the specified risk window.
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 3 days after Dose 3
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Person days at risk
OG00073660
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
4 to 7 days after Dose 3
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Person days at risk
OG00073660
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 7 days after Dose 3
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Person days at risk
OG000147320
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 3 days after Dose 3
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Person days at risk
OG00073601
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.367(0.252 to 0.535)
OG0012.834(1.884 to 4.265)
Primary
Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
4 to 7 days after Dose 3
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Person days at risk
OG00073634
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.190(0.113 to 0.321)
OG0010.489(0.184 to 1.303)
Primary
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 7 days after Dose 3
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Person days at risk
OG000147127
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.279(0.205 to 0.379)
OG0011.604(1.092 to 2.356)
Primary
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 3 days after Dose 4
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Person days at risk
OG00051766
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.058(0.019 to 0.180)
OG001NA(NA to NA)Data was not estimable as no participant had seizures during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
4 to 7 days after Dose 4
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Person days at risk
OG00051775
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.039(0.010 to 0.155)
OG001NA(NA to NA)Data was not estimable as no participant had seizures during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 7 days after Dose 4
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Person days at risk
OG000103529
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.048(0.020 to 0.116)
OG001NA(NA to NA)Data was not estimable as no participant had seizures during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 3 days after Dose 4
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Person days at risk
OG00051776
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
4 to 7 days after Dose 4
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Person days at risk
OG00051776
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.019(0.003 to 0.137)
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 7 days after Dose 4
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Person days at risk
OG000103551
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.010(0.001 to 0.069)
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 3 days after Dose 4
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Person days at risk
OG00051741
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0000.29(0.175 to 0.481)
OG0010.388(0.097 to 1.550)
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
4 to 7 days after Dose 4
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Person days at risk
OG00051727
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0000.483(0.327 to 0.715)
OG001NA(NA to NA)Data was not estimable as no participant had urticaria during the specified risk window.
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 7 days after Dose 4
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Person days at risk
OG000103407
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0000.387(0.284 to 0.527)
OG0010.194(0.049 to 0.775)
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 3 days after Dose 4
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Person days at risk
OG00051776
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
4 to 7 days after Dose 4
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Person days at risk
OG00051776
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 7 days after Dose 4
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Person days at risk
OG000103552
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 3 days after Dose 4
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Person days at risk
OG00051641
OG001
Title
Denominators
Categories
Title
Measurements
OG0001.278(1.004 to 1.627)
OG00115.822(12.673 to 19.753)
Primary
Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
4 to 7 days after Dose 4
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Person days at risk
OG00051622
OG001
Title
Denominators
Categories
Title
Measurements
OG0001.298(1.022 to 1.649)
OG0013.124(1.914 to 5.1)
Primary
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 7 days after Dose 4
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Person days at risk
OG000103028
OG001
Title
Denominators
Categories
Title
Measurements
OG0001.194(1.001 to 1.425)
OG0019.54(7.785 to 11.690)
Primary
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 3 Days after all Doses
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG000284246
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.011(0.003 to 0.033)
OG001NA(NA to NA)Data was not estimable as no participant had seizures during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
4 to 7 Days after all Doses
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG000284252
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.014(0.005 to 0.038)
OG001NA(NA to NA)Data was not estimable as no participant had seizures during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 7 Days after all Doses
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG000568486
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.012(0.006 to 0.026)
OG001NA(NA to NA)Data was not estimable as no participant had seizures during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 3 Days after all Doses
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG000284256
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had febrile seizures during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizures during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
4 to 7 Days after all Doses
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG000284254
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.007(0.002 to 0.028)
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizures during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 7 Days after all Doses
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG000568510
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.004(0.001 to 0.014)
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizures during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 3 days after all Doses
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG000284202
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0000.088(0.059 to 0.130)
OG0010.223(0.106 to 0.468)
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
4 to 7 days after all Doses
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG000284162
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0000.165(0.124 to 0.220)
OG001NA(NA to NA)Data was not estimable as no participant had urticaria during the specified risk window.
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 7 days after all Doses
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG000568263
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0000.127(0.101 to 0.160)
OG0010.112(0.053 to 0.234)
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 3 days after all doses
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG000284256
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
4 to 7 days after all doses
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG000284256
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 7 days after all doses
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG000568512
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 3 days after all doses
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG000283817
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.627(0.542 to 0.726)
OG0017.575(6.660 to 8.615)
Primary
Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
4 to 7 days after all doses
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG000284051
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.331(0.270 to 0.405)
OG0010.958(0.67 to 1.371)
Primary
Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 person-days
0 to 7 days after all doses
Person days at risk
Person days at risk
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Person days at risk
OG000567188
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.458(0.406 to 0.518)
OG0014.261(3.774 to 4.812)
Primary
Incidence Rate (IR) (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 3 days after Dose 1
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00020318
OG0012300
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had seizure during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
4 to 7 days after Dose 1
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00020318
OG0012300
Title
Denominators
Categories
Title
Measurements
OG0000.098(0.025 to 0.394)
OG001NA(NA to NA)Data was not estimable as no participant had seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 7 days after Dose 1
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00020318
OG0012300
Title
Denominators
Categories
Title
Measurements
OG0000.098(0.025 to 0.394)
OG001NA(NA to NA)Data was not estimable as no participant had seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 3 days after Dose 1
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00020318
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
4 to 7 days after Dose 1
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00020318
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.049(0.007 to 0.349)
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 7 days after Dose 1
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00020318
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.049(0.007 to 0.349)
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 3 days after Dose 1
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00020318
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0000.049(0.007 to 0.349)
OG0011.304(0.421 to 4.044)
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
4 to 7 days after Dose 1
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00020318
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0000.098(0.025 to 0.394)
OG001NA(NA to NA)Data was not estimable as no participant had urticaria during the specified risk window.
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 7 days after Dose 1
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00020318
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0000.148(0.048 to 0.458)
OG0011.304(0.421 to 4.044)
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 3 days after Dose 1
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00020318
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
4 to 7 days after Dose 1
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00020318
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 7 days after Dose 1
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00020318
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 3 days after Dose 1
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00020318
OG0012300
Title
Denominators
Categories
Title
Measurements
OG0002.215(1.654 to 2.966)
OG00141.304(33.780 to 50.504)
Primary
Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
4 to 7 days after Dose 1
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00020318
OG0012300
Title
Denominators
Categories
Title
Measurements
OG0000.197(0.074 to 0.525)
OG0012.174(0.905 to 5.223)
Primary
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 1
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 7 days after Dose 1
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00020318
OG0012300
Title
Denominators
Categories
Title
Measurements
OG0002.362(1.780 to 3.135)
OG00143.478(35.74 to 52.892)
Primary
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 3 days after Dose 2
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Doses
OG00019387
OG0012203
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had seizure during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
4 to 7 days after Dose 2
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Doses
OG00019387
OG0012203
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had seizure during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 7 days after Dose 2
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Doses
OG00019387
OG0012203
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had seizure during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 3 days after Dose 2
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Doses
OG00019387
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
4 to 7 days after Dose 2
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Doses
OG00019387
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 7 days after Dose 2
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Doses
OG00019387
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 3 days after Dose 2
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Doses
OG00019387
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0000.258(0.107 to 0.620)
OG0010.908(0.227 to 3.630)
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
4 to 7 days after Dose 2
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Doses
OG00019387
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0000.516(0.278 to 0.959)
OG001NA(NA to NA)Data was not estimable as no participant had urticaria during the specified risk window.
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 7 days after Dose 2
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Doses
OG00019387
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0000.774(0.466 to 1.283)
OG0010.908(0.227 to 3.630)
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 3 days after Dose 2
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Doses
OG00019387
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
4 to 7 days after Dose 2
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Doses
OG00019387
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 7 days after Dose 2
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Doses
OG00019387
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 3 days after Dose 2
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Doses
OG00019387
OG0012203
Title
Denominators
Categories
Title
Measurements
OG0002.063(1.513 to 2.813)
OG00116.341(11.788 to 22.655)
Primary
Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
4 to 7 days after Dose 2
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Doses
OG00019387
OG0012203
Title
Denominators
Categories
Title
Measurements
OG0000.464(0.242 to 0.892)
OG0012.270(0.945 to 5.453)
Primary
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 2
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 7 days after Dose 2
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00019387
OG0012203
Doses
OG00019387
OG0012203
Title
Denominators
Categories
Title
Measurements
OG0002.476(1.866 to 3.285)
OG00118.611(13.704 to 25.276)
Primary
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 3 days after Dose 3
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Doses
OG00018415
OG0012047
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had seizure during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
4 to 7 days after Dose 3
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Doses
OG00018415
OG0012047
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had seizures during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had seizures during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 7 days after Dose 3
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Doses
OG00018415
OG0012047
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had seizure during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 3 days after Dose 3
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Doses
OG00018415
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
4 to 7 days after Dose 3
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Doses
OG00018415
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 7 days after Dose 3
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Doses
OG00018415
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 3 days after Dose 3
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Doses
OG00018415
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0000.217(0.082 to 0.579)
OG001NA(NA to NA)Data was not estimable as no participant had urticaria during the specified risk window.
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
4 to 7 days after Dose 3
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Doses
OG00018415
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0000.543(0.292 to 1.009)
OG001NA(NA to NA)Data was not estimable as no participant had urticaria during the specified risk window.
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 7 days after Dose 3
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Doses
OG00018415
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0000.760(0.450 to 1.284)
OG001NA(NA to NA)Data was not estimable as no participant had urticaria during the specified risk window.
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 3 days after Dose 3
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Doses
OG00018415
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
4 to 7 days after Dose 3
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Doses
OG00018415
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 7 days after Dose 3
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Doses
OG00018415
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 3 days after Dose 3
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Doses
OG00018415
OG0012047
Title
Denominators
Categories
Title
Measurements
OG0001.466(1.006 to 2.138)
OG00111.236(7.467 to 16.908)
Primary
Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
4 to 7 days after Dose 3
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Doses
OG00018415
OG0012047
Title
Denominators
Categories
Title
Measurements
OG0000.760(0.450 to 1.284)
OG0011.954(0.733 to 5.207)
Primary
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 3
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 7 days after Dose 3
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00018415
OG0012047
Doses
OG00018415
OG0012047
Title
Denominators
Categories
Title
Measurements
OG0002.226(1.639 to 3.024)
OG00112.702(8.648 to 18.655)
Primary
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 3 days after Dose 4
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Doses
OG00012944
OG0011291
Title
Denominators
Categories
Title
Measurements
OG0000.232(0.075 to 0.719)
OG001NA(NA to NA)Data was not estimable as no participant had seizures during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
4 to 7 days after Dose 4
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Doses
OG00012944
OG0011291
Title
Denominators
Categories
Title
Measurements
OG0000.155(0.039 to 0.618)
OG001NA(NA to NA)Data was not estimable as no participant had seizures during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 7 days after Dose 4
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Doses
OG00012944
OG0011291
Title
Denominators
Categories
Title
Measurements
OG0000.386(0.161 to 0.928)
OG001NA(NA to NA)Data was not estimable as no participant had seizures during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 3 days after Dose 4
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Doses
OG00012944
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
4 to 7 days after Dose 4
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Doses
OG00012944
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.077(0.011 to 0.548)
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 7 days after Dose 4
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Doses
OG00012944
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.077(0.011 to 0.548)
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizure during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 3 days after Dose 4
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Doses
OG00012944
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0001.159(0.699 to 1.922)
OG0011.549(0.387 to 6.194)
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
4 to 7 days after Dose 4
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Doses
OG00012944
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0001.931(1.305 to 2.858)
OG001NA(NA to NA)Data was not estimable as no participant had urticaria during the specified risk window.
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 7 days after Dose 4
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Doses
OG00012944
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0003.090(2.267 to 4.213)
OG0011.549(0.387 to 6.194)
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 3 days after Dose 4
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Doses
OG00012944
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
4 to 7 days after Dose 4
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Doses
OG00012944
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 7 days after Dose 4
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Doses
OG00012944
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 3 days after Dose 4
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Doses
OG00012944
OG0011291
Title
Denominators
Categories
Title
Measurements
OG0005.099(4.006 to 6.490)
OG00160.418(48.394 to 75.431)
Primary
Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
4 to 7 days after Dose 4
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Doses
OG00012944
OG0011291
Title
Denominators
Categories
Title
Measurements
OG0005.176(4.074 to 6.577)
OG00112.394(7.593 to 20.230)
Primary
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 4
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 7 days after Dose 4
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00012944
OG0011291
Doses
OG00012944
OG0011291
Title
Denominators
Categories
Title
Measurements
OG0009.503(7.963 to 11.339)
OG00172.037(58.788 to 88.272)
Primary
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 3 days after all doses
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00071064
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.042(0.014 to 0.131)
OG001NA(NA to NA)Data was not estimable as no participant had seizures during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
4 to 7 days after all doses
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00071064
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.056(0.021 to 0.15)
OG001NA(NA to NA)Data was not estimable as no participant had seizures during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 7 days after all doses
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00071064
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.099(0.047 to 0.207)
OG001NA(NA to NA)Data was not estimable as no participant had seizures during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 3 days after all doses
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00071064
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had febrile seizures during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizures during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
4 to 7 days after all doses
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00071064
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.028(0.007 to 0.113)
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizures during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 7 days after all doses
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00071064
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.028(0.007 to 0.113)
OG001NA(NA to NA)Data was not estimable as no participant had febrile seizures during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 3 days after all Doses
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00071064
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0000.352(0.238 to 0.521)
OG0010.893(0.426 to 1.873)
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
4 to 7 days after all Doses
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00071064
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0000.661(0.497 to 0.880)
OG001NA(NA to NA)Data was not estimable as no participant had urticaria during the specified risk window.
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 7 days after all Doses
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00071064
OG001
Title
Denominators
Categories
Urticaria
Title
Measurements
OG0001.013(0.804 to 1.276)
OG0010.893(0.426 to 1.873)
Angioedema
Title
Measurements
OG000
Primary
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 3 days after all Doses
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00071064
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
4 to 7 days after all Doses
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00071064
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 7 days after all Doses
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00071064
OG001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had apnea during the specified risk window.
Primary
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 3 days after all doses
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00071064
OG0017841
Title
Denominators
Categories
Title
Measurements
OG0002.505(2.163 to 2.901)
OG00129.588(26.016 to 33.651)
Primary
Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
4 to 7 days after all doses
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00071064
OG0017841
Title
Denominators
Categories
Title
Measurements
OG0001.323(1.081 to 1.619)
OG0013.826(2.675 to 5.472)
Primary
Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After All Doses
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.
Analysis population included all participants included in the main study cohort and prospective cohort respectively.
Posted
Number
95% Confidence Interval
Events per 1000 doses
0 to 7 days after all doses
Doses
Doses
ID
Title
Description
OG000
Prevenar 13: Main Study Cohort
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.
OG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
Units
Counts
Participants
OG00020318
OG0012300
Doses
OG00071064
OG0017841
Title
Denominators
Categories
Title
Measurements
OG0003.659(3.240 to 4.132)
OG00133.159(29.364 to 37.445)
0
0
0
0
0
0
EG001
Prevenar 13 Cohort: Prospective Cohort Study
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.
0
0
0
0
0
0
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
D017445
Skin Diseases, Vascular
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
D006969
Hypersensitivity, Immediate
D006967
Hypersensitivity
D007154
Immune System Diseases
D014652
Vascular Diseases
D002318
Cardiovascular Diseases
D012120
Respiration Disorders
D012140
Respiratory Tract Diseases
D012818
Signs and Symptoms, Respiratory
D001832
Body Temperature Changes
9200
18400
9200
9200
18400
9197
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
9200
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
18385
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
9200
9200
18400
8888
9195
17702
8812
8812
17624
8812
8812
17624
8808
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
8812
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
17612
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
8812
8812
17624
8696
8808
17360
8188
8188
16376
8188
8188
16376
8188
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
8188
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
16376
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
8188
8188
16376
8115
8180
16206
5164
5164
10328
5164
5164
10328
5160
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
5164
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
10316
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
5164
5164
10328
4930
5121
9749
31364
31364
62728
31364
31364
62728
31353
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
31364
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
62689
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
31364
31364
62728
30628
31303
61016
2300
2300
2300
2300
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
2300
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
2300
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
2300
2300
2300
2203
2203
2203
2203
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
2203
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
2203
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
2203
2203
2203
2047
2047
2047
2047
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
2047
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
2047
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
2047
2047
2047
1291
1291
1291
1291
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
1291
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
1291
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
1291
1291
1291
7841
7841
7841
7841
7841
7841
7841
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
7841
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.
7841
NA
(NA to NA)
Data was not estimable as no participant had angioedema during the specified risk window.
OG001NA(NA to NA)Data was not estimable as no participant had angioedema during the specified risk window.