A Safety Study For Prevenar 13 Among Chinese Children

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-01

Study Completion Date

2020-07-31

Brief Summary

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This is an observational study based on a population-based EHR database.

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Detailed Description

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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

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Seizures Urticaria and Angioedema Apnea Fever

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Prevenar 13 cohort

This is a non-interventional study. Children in the study receive Prevenar 13 per normal medical practice.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

1 Month

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No