Gardasil Vaccination and Venous Thromboembolism (PRISM)

    Basic Details
    Date Posted
    Tuesday, April 21, 2015
    Status
    Complete
    Medical Product
    Gardasil
    Health Outcome(s)
    venous thromboembolism (VTE)
    Description

    Project to assess the risk of venous thromboembolism (VTE) following Gardasil vaccination in 9-26 year-old females using a self-controlled risk interval design. Gardasil doses and VTE cases will be identified in electronic healthcare databases and undergo medical record review. Secondary analyses will adjust for the baseline risk of combined hormonal contraceptive use. The protocol represents a customized study design.

    The Mini-Sentinel Operations Center posted the final draft protocol for public comment from March 30, 2012 through April 13, 2012. The public comment period is now closed. Revised versions were approved for implementation by FDA on April 1, 2014, and on November 18, 2014. A log of changes is included in the latest revised protocol (v2.1).

    Additional Details
    FDA Center
    CBER
    Time Period
    2006 - 2011
    Study Type
    Protocol/Surveillance Plan
    Assessment Type
    Safety Analyses
    HOI Study Type
    Validations Supported by Traditional Medical Chart Review
    Population / Cohort
    All females 9-26 years of age
    Data Sources
    Mini-Sentinel Distributed Dataset (MSDD); immunization registry data from any of the nine participating registries (also known as immunization information systems (IIS))
    Workgroup Leader(s)

    Michael D. Nguyen, MD; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

    Sharon K. Greene, PhD, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

    Workgroup Members

    W. Katherine Yih, PhD, MPH; Martin Kulldorff, PhD; Tracy A. Lieu, MD, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA 

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

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

    Vinit P. Nair BPharm, MS, RPh; Comprehensive Health Insights, Humana Inc., Louisville, KY 

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