Gardasil Vaccination and Venous Thromboembolism (PRISM)

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Details

Basic Details

Date Posted:

Tuesday, April 21, 2015

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 Information

Additional Details

FDA Center:

CBER

Time Period:

2006 - 2011

Study Type:

Protocol/Surveillance Plan

Assessment Type:

Safety Analyses

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))

Contributors

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

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Assessments

Gardasil Vaccination and Venous Thromboembolism (PRISM)

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