Pilot Of Self-Controlled Tree-Temporal Scan Analysis For Gardasil Vaccine

Project Title Pilot Of Self-Controlled Tree-Temporal Scan Analysis For Gardasil Vaccine
Date Posted
Friday, September 30, 2016
Status
Complete
Deliverables
Description

Methods project to develop test unconditional and conditional variants of the self-controlled tree-temporal scan statistic, both with and without day-of-week adjustment using Gardasil human papillomavirus quadrivalent vaccine (types 6, 11, 16, 18) as the test vaccine.
 
The Mini-Sentinel Operations Center posted this final draft protocol for public comment from February 9, 2015 through February 23, 2015.  A revised version was approved for implementation by FDA on March 30, 2015. A log of changes is included in the revised protocol (v2.0).

Workgroup Leader(s)

W. Katherine Yih PhD, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Martin Kulldorff PhD; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA

Adamma Mba-Jonas MD, MPH; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

Workgroup Members

Meghan A. Baker MD, ScD; Carolyn Balsbaugh MPH; Jeffrey Brown PhD; David Cole BM; Inna Dashevsky MS; Judith C. Maro PhD, MS; Megan Reidy MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Medical Product
Gardasil vaccine
Data Sources
Mini-Sentinel Distributed Database (MSDD)
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