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

Project Title Assessment of Quadrivalent Human Papillomavirus Vaccine Safety Using the Self-Controlled Tree-Temporal Scan Statistic Signal-Detection Method in the Sentinel System
Date
Thursday, February 22, 2018
Location
Description

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). 

Medical Product
quadrivalent human papillomavirus vaccination (HPV4)
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: katherine_yih@harvardpilgrim.org

Authors

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

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