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A Safety Study For Prevenar 13 Among Chinese Children

Last updated on October 18, 2019

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 TitleA Safety Study For Prevenar 13 Among Chinese Children
Official TitleAN OBSERVATIONAL SAFETY STUDY FOR PREVENAR 13 AMONG CHINESE CHILDREN
Brief SummaryThis is an observational study based on a population-based EHR database.
Detailed DescriptionThis 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 TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Other
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-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
InterventionNot Provided
Study Groups/CohortsPrevenar 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 StatusActive, not recruiting
Estimated Enrollment
 (submitted: August 30, 2018)
1
Original Estimated EnrollmentSame as current
Estimated Study Completion DateSeptember 30, 2020
Estimated Primary Completion DateSeptember 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
Ages1 Month to 24 Months   (Child)
Accepts Healthy VolunteersYes
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesChina
Removed Location Countries  
 
Administrative Information
NCT NumberNCT03656939
Other Study ID NumbersB1851193
Has Data Monitoring CommitteeNo
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 PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 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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