Accessing the Freshest Feasible Data for Conducting Active Influenza Vaccine Safety Surveillance (PRISM)

    Basic Details
    Date Posted
    Monday, April 6, 2015
    Status
    Complete
    Medical Product
    influenza vaccine
    Health Outcome(s)
    anaphylaxis
    febrile seizure
    Description

    Project to establish and assess an active surveillance system for seasonal influenza vaccines. Protocol-based assessments use study designs and analysis plans customized for the product-outcome pairs being assessed.

    This protocol was posted for public comment from August 2, 2013 through August 16, 2013. The public comment period is now closed. Revised versions of the protocol were approved for implementation by FDA on September 10, 2013, and December 31, 2013. A log of changes is included in the most recently revised protocol (v3.0).

    Additional Details
    FDA Center
    CBER
    Study Type
    Protocol/Surveillance Plan
    Assessment Type
    Safety Analyses
    Population / Cohort
    All children 6-59 months of age
    Data Sources
    Mini-Sentinel Distributed Database (MSDD) and immunization registries in Florida, Indiana, Michigan, Minnesota, New York City, New York State, Pennsylvania, Virginia, and Wisconsin
    Workgroup Leader(s)

    Katherine Yih, PhD, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

    Sukhminder Sandhu, PhD, MPH, MS; Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD

    Workgroup Members

    Grace M. Lee, MD, MPH; Ruihua Yin, MS; Robert Jin, MS; David Cole, BM; Lauren Zichittella, MS; Alison Tse Kawai, ScD; Martin Kulldorff, PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

    Michael Nguyen, MD; Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD

    Cheryl N McMahill-Walraven, PhD, MSW; Aetna Data Science, Aetna, Blue Bell, PA 

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

    Nandini Selvam, PhD, MPH; Government & Academic Research, HealthCore, Alexandria, VA