Influenza Vaccines and Febrile Seizures (PRISM)

    Basic Details
    Date Posted
    Friday, September 18, 2015
    Status
    Complete
    Medical Product
    influenza vaccine
    Health Outcome(s)
    febrile seizure
    Description

    Protocol-based assessment of the risk of febrile seizures following trivalent inactivated influenza vaccine administered during the 2010-11 influenza season among children ages 6 months through 59 months using a self-controlled risk interval design. Influenza vaccinations and febrile seizure cases were identified in electronic healthcare databases and underwent medical record review. The positive predictive value of three alternative febrile seizures definitions that use ICD9 data was evaluated. 

    The information contained in this report is associated with an FDA Safety Communication issued on May 16, 2014. Click here to see the Safety Communication.

    This protocol was posted for public comment from January 24, 2013 through February 7, 2013. A revised version was approved for implementation by FDA on April 26, 2013. A log of changes is included in the revised protocol (v2.0).

    Additional Details
    FDA Center
    CBER
    Time Period
    2010 - 2011
    Study Type
    Protocol/Surveillance Plan
    Assessment Type
    Safety Analyses
    HOI Study Type
    Validations Supported by Traditional Medical Chart Review
    Population / Cohort
    All children 6 - 59 months of age
    Data Sources
    Mini-Sentinel Distributed Database (MSDD) and immunization registries in Florida, Michigan, Minnesota, New York City, New York State, Pennsylvania, Virginia, and Wisconsin
    Workgroup Leader(s)

    Alison Kawai, ScD; Grace Lee, MD, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

    Workgroup Members

    Martin Kulldorff, PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

    David Martin, MD, MPH; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

    Cheryl McMahill-Walraven, PhD, MSW; Aetna: Aetna Informatics, Blue Bell, PA

    Mano Selvan, PhD, Comprehensive Health Insights, Humana, Louisville, KY

    Nandini Selvam, PhD, MPH; HealthCore, Inc., Alexandria, VA