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Mini-Sentinel: Pilot Of Self-Controlled Tree-Temporal Scan Analysis For Gardasil Vaccine

    Basic Details
    Date Posted
    Friday, September 30, 2016
    Status
    Complete
    Medical Product
    Gardasil
    Description

    Methods project to develop test unconditional and conditional variants of the self-controlled tree-temporal scan statistic, both with and without day-of-week adjustment using Gardasil human papillomavirus quadrivalent vaccine (types 6, 11, 16, 18) as the test vaccine.
     
    The Mini-Sentinel Operations Center posted this final draft protocol for public comment from February 9, 2015 through February 23, 2015.  A revised version was approved for implementation by FDA on March 30, 2015. A log of changes is included in the revised protocol (v2.0).

    Workgroup Leader(s)

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

    Martin Kulldorff, PhD; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA

    Adamma Mba-Jonas, MD, MPH; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

    Workgroup Member(s)

    Meghan A. Baker, MD, ScD; Carolyn Balsbaugh, MPH; Jeffrey Brown, PhD; David Cole, BM; Inna Dashevsky, MS; Judith C. Maro, PhD, MS; Megan Reidy, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA