Loading clinical trials...

A Safety Study For Prevenar 13 Among Chinese Children | Clinical Trials | Clareo Health

COMPLETED

A Safety Study For Prevenar 13 Among Chinese Children

AN OBSERVATIONAL SAFETY STUDY FOR PREVENAR 13 AMONG CHINESE CHILDREN

NCT03656939•Pfizer

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 2 years

Sex

ALL

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.

Locations (1)

School of Public Health at Fudan University

Shanghai, China

Key Dates

Start Date

August 1, 2018

Primary Completion Date

July 31, 2020

Completion Date

July 31, 2020

Last Updated

August 27, 2021

Enrollment

21,240

ACTUAL participants

Conditions

SeizuresUrticaria and AngioedemaApneaFever

OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia

NCT06430957

Obstructive Sleep Apnea Risk ManagementPostoperative Complications+2 more

View study

RECRUITINGNA

Digital-supported Orofacial Myofunctional Therapy in OSA

NCT07292922

Obstructive Sleep Apnea (OSA)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 27, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Safety Study For Prevenar 13 Among Chinese Children

Inclusion Criteria

OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia

Digital-supported Orofacial Myofunctional Therapy in OSA

A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures

Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy

Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome