|Project Title||Evaluation of HPV9 (Gardasil9) Vaccine Safety Surveillance Using the TreeScan Data Mining Method Surveillance Protocol|
Thursday, June 30, 2016
This protocol will use tree-based scan statistics for the following objectives:
The Sentinel Operations Center posted this final draft surveillance protocol for public comment from June 30, 2016 through July 14, 2016. The public comment period is now closed.
The workgroup will consider all comments, but under most circumstances will not reply directly to commenters. Any revisions done to this surveillance protocol subsequent to the public comment period will be noted in the change log document included in the amended surveillance protocol. Posting of the revised document will be listed on the Mini-Sentinel homepage, on the relevant assessments project details page, and in the Mini-Sentinel RSS feed.
9-valent human papillomavirus (HPV9) vaccine
|Population / Cohort|
All individuals 9-26 years of age
2006 - 2015
W. Katherine Yih PhD, MPH; Judith C. Maro PhD, MS; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Estelle Russek-Cohen PhD; Azadeh Shoaibi PhD, MHS; Lihan Yan PhD; Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD
Meghan A. Baker MD, ScD; David Cole BM; Inna Dashevsky MS; Megan Reidy 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
Steven Anderson PhD, MPP; Adamma Mba-Jonas MD, MPH; Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD
Sentinel Distributed Database (SDD)