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).
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
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