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Gardasil Vaccination and Venous Thromboembolism (PRISM)

Basic Details
Date Posted
Status
Complete
Medical Product
Gardasil
Health Outcome(s)
venous thromboembolism (VTE)
Description

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).

Deliverables (2)
Mini-Sentinel PRISM Gardasil and Venous Thromboembolism Protocol Mini-Sentinel PRISM Gardasil and Venous Thromboembolism Report
Additional Details
FDA Center
CBER
Time Period
2006 - 2011
HOI Study Type
Validations Supported by Traditional Medical Chart Review
Population / Cohort
All females 9-26 years of age
Data Sources
Mini-Sentinel Distributed Dataset (MSDD); immunization registry data from any of the nine participating registries (also known as immunization information systems (IIS))
Related Links
FDA Sentinel Study Finds No Association between Venous Thromboembolism and Gardasil Vaccination
Absence of Venous Thromboembolism Risk Following Quadrivalent Human Papillomavirus Vaccination, Vaccine Safety Datalink, 2008–2011
Venous Thromboembolism Algorithm Defined in "Gardasil Vaccination and Venous Thromboembolism (PRISM)"
Workgroup Leader(s)

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

Workgroup Members

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