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Assessment of Quadrivalent Human Papillomavirus Vaccine Safety Using the Self-Controlled Tree-Temporal Scan Statistic Signal-Detection Method in the Sentinel System

    Basic Details
    Medical Product
    quadrivalent human papillomavirus vaccination (HPV4)

    The self-controlled tree-temporal scan statistic—a new signal-detection method—can evaluate whether any of a wide variety of health outcomes are temporally associated with receipt of a specific vaccine, while adjusting for multiple testing. Neither health outcomes nor post-vaccination potential periods of increased risk need be pre-specified. Using US medical claims data in the Sentinel System, the method was used to evaluate adverse events after quadrivalent human papillomavirus vaccine (4vHPV). 


    W. Katherine Yih, PhD, MPH; Judith C. Maro, PhD; Michael Nguyen, MD; Meghan A. Baker, MD, ScD; Carolyn Balsbaugh, MPH; David V. Cole, BM; Inna Dashevsky, MS; Adamma Mba-Jonas, MD; Martin Kulldorff, PhD

    Corresponding Author

    W. K. Yih, Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, 401 Park Drive, Suite 401 East, Boston, MA. Email: