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).
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
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