Evaluation of HPV9 (Gardasil9) Vaccine Safety Surveillance Using the TreeScan Data Mining Method Surveillance Protocol

    Basic Details
    Date Posted
    Thursday, June 30, 2016
    Status
    Complete
    Medical Product
    9-valent human papillomavirus (HPV9) vaccine
    Description

    This protocol will use tree-based scan statistics for the following objectives:

    1. To assess the safety of HPV9 vaccine in females and males ages 9 through 26 years, using the conditional self-controlled tree-temporal scan statistic, evaluating thousands of potential adverse events
    2. To conduct an initial evaluation of any alerts detected, using clinical judgment to review summary statistics and electronically generated claims profiles of the patients contributing to the alert

    The Sentinel Operations Center posted this final draft surveillance protocol for public comment from June 30, 2016 through July 14, 2016. The public comment period is now closed.

    The workgroup will consider all comments, but under most circumstances will not reply directly to commenters. Any revisions done to this surveillance protocol subsequent to the public comment period will be noted in the change log document included in the amended surveillance protocol. Posting of the revised document will be listed on the Mini-Sentinel homepage, on the relevant assessments project details page, and in the Mini-Sentinel RSS feed.

    Additional Details
    FDA Center
    CBER
    Time Period
    2006 - 2015
    Study Type
    Protocol/Surveillance Plan
    Assessment Type
    Safety Analyses
    Population / Cohort
    All individuals 9-26 years of age
    Data Sources
    Sentinel Distributed Database (SDD)
    Workgroup Leader(s)

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

    Estelle Russek-Cohen, PhD; Azadeh Shoaibi, PhD, MHS; Lihan Yan, PhD; Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD

    Workgroup Members

    Meghan A. Baker, MD, ScD; David Cole, BM; Inna Dashevsky, MS; Megan Reidy, 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

    Steven Anderson, PhD, MPP; Adamma Mba-Jonas, MD, MPH; Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD