A Safety Study For Prevenar 13 Among Chinese Children

Pfizer

Status

Completed

Conditions

Fever

Seizures

Apnea

Urticaria and Angioedema

Study type

Observational

Funder types

Industry

Identifiers

NCT03656939

B1851193

Details and patient eligibility

About

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

Full 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.

Enrollment

21,240 patients

Sex

All

Ages

1 to 24 months old

Volunteers

No Healthy Volunteers

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.