Results from Assessments of Health Outcomes Among Individuals Exposed to Medical Products Search
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| Project Title | Gardasil vaccination and venous thromboembolism (PRISM) |
| Date Posted |
3-30-2012
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| Project Status | In progress |
| Assessment Type | Protocol based one-time assessment |
| Description |
Protocol 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 this final draft protocol for public comment from March 30, 2012 through April 13, 2012. The public comment period is now closed.
Any revisions done to this protocol in response to comments received will be noted in the change log document posted along with the amended protocol. Posting of both documents will be listed on the Mini-Sentinel homepage, on the relevant assessments project details page, and in the Mini-Sentinel RSS feed.
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| Medical Product | Gardasil |
| Health Outcome | Venous thromboembolism |
| Population / Cohort | Females ages 9-26 years |
| Time Period | June 2006 to December 2011 |
| Workgroup Leaders | Michael D. Nguyen, MD, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD; Sharon K. Greene, PhD, MPH, Department of Population Medicine, Harvard Medical School / Harvard Pilgrim Health Care Institute, Boston, MA |
| Workgroup Members | W. Katherine Yih, PhD, MPH, Martin Kulldorff, PhD, and Tracy A. Lieu, MD, MPH, Department of Population Medicine, Harvard Medical School / Harvard Pilgrim Health Care Institute, Boston, MA; David B. Martin, MD, MPH, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD; Nandini Selvam, PhD, MPH, HealthCore Inc, Alexandria, VA; Vinit P. Nair, BS Pharm, MS, RPh, Humana, Louisville, KY; Cheryl N. McMahill-Walraven, MSW, PhD, Aetna Informatics, Blue Bell, PA |
| Data Sources | A subset of the Mini-Sentinel Distributed Dataset (MSDD); immunization registry data from any of the nine participating registries (also known as immunization information systems (IIS)) |
| Deliverables |
Monitoring For Venous Thromboembolism After Gardasil Vaccination
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| Related Links |
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| Keywords | Mini-Sentinel, PRISM, active surveillance, validation, electronic algorithms, epidemiologic methods, monitoring vaccine-outcome pairs, Gardasil, human papillomavirus, HPV, venous thromboembolism, Nguyen, Greene, Yih, Kulldorff, Lieu, Martin, Selvam, Nair, McMahill-WalravenWalraven |
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