Pneumococcal Conjugate Vaccines and Kawasaki Disease

    Basic Details
    Date Posted
    Thursday, May 29, 2014
    Status
    Complete
    Medical Product
    13-valent pneumococcal vaccine (PCV13)
    7-valent pneumococcal conjugate vaccine (PCV7)
    generic pneumococcal conjugate vaccine (PCV)
    Health Outcome(s)
    Kawasaki disease
    Description

    Modular program-based one-time assessment of pneumococcal conjugate vaccines (PCV7, PCV13, Generic PCV) and Kawasaki’s. Results include prevalent and incident use of pneumococcal conjugate vaccines, prevalent and incident Kawasaki’s disease diagnoses, and diagnoses of Kawasaki's Disease following incident vaccination with pneumococcal conjugate vaccines.  The query was run against the Mini-Sentinel Distributed Database for the time period of interest January 1, 2004 through March 31, 2012.  Modular programs are adaptable standardized programs.  Results were generated using Modular Program 5, version 2.1; and Modular Program 3, version 2.5; click here for more information. The queries were distributed in August/September 2012.  This report includes data from 4 Data Partners.

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    Additional Details
    FDA Center
    CBER
    Time Period
    January 1, 2004 - March 31, 2012
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)