Influenza Vaccines and Febrile Seizures in the 2013-2014 and 2014-2015 Influenza Seasons

    Basic Details
    Date Posted
    Friday, November 10, 2017
    Status
    Complete
    Medical Product
    influenza vaccine
    Prevnar 13
    Health Outcome(s)
    febrile seizure
    Description

    This project was a protocol-based assessment. Evidence on the risk of febrile seizures (FS) after vaccination with inactivated vaccine (IIV) and 13-valent pneumococcal conjugate vaccine (PCV13) is mixed. Among children 6-23 months, we examined the risk of FS following IIV and PCV13 during the 2013-14 and 2014-15 influenza seasons, for which vaccine virus strains were the same.

    The Mini-Sentinel Operations Center posted this protocol for public comment from September 11, 2015 through September 25, 2015.  A revised version was approved for implementation by FDA on July 22, 2016. A log of changes is included in the revised protocol (v2).

    Additional Details
    FDA Center
    CBER
    Time Period
    2013 - 2015
    Study Type
    Protocol/Surveillance Plan
    Assessment Type
    Safety Analyses
    Population / Cohort
    All children 6 - 23 months of age
    Workgroup Leader(s)

    Meghan Baker, MD, ScD; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA

    Christopher Jankosky, MD; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

    Workgroup Members

    Noelle Cocoros, DSc, MPH; Katherine Yih, PhD, MPH; Alison Kawai, ScD; Lingling Li, PhD; Grace M. Lee, MD, MPH; David Cole, BM; Lauren Zichittella, MS; Sandra Feibelmann, MPH; Diana Santiago, MSPH; Megan Reidy, MPH; Hana Lipowicz, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

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

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

    Mano S. Selvan, PhD; Comprehensive Health Insights, Humana Inc., Louisville, KY

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

    Nancy Lin, ScD; OptumInsight Inc., Waltham, MA