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A Safety Study For Prevenar 13 Among Chinese Children

Last updated on February 19, 2020

FOR MORE INFORMATION
Study Location
School of Public Health at Fudan University
Shanghai, , 200032 China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Seizures, Urticaria and Angioedema, Apnea, Fever
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
1-24 month
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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 July 1st, 2018 and July 24th, 2020 and
an informed consent must be obtained from parents/legal guardians.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

There are no exclusion criteria for this study.

NCT03656939
Pfizer
Active, not recruiting
A Safety Study For Prevenar 13 Among Chinese Children

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Descriptive Information
Brief Title A Safety Study For Prevenar 13 Among Chinese Children
Official Title AN OBSERVATIONAL SAFETY STUDY FOR PREVENAR 13 AMONG CHINESE CHILDREN
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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 July 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.

Condition
  • Seizures
  • Urticaria and Angioedema
  • Apnea
  • Fever
Intervention Not Provided
Study Groups/Cohorts Prevenar 13 cohort
This is a non-interventional study. Children in the study receive Prevenar 13 per normal medical practice.
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: August 30, 2018)
1
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
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 July 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 1 Month to 24 Months   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03656939
Other Study ID Numbers B1851193
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: 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/da....
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2019

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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