Evaluation of HPV9 (Gardasil9) Vaccine Safety Surveillance Using the TreeScan Data Mining Method Surveillance Protocol

Basic Details
Date Posted
Thursday, June 30, 2016
Status
Complete
Medical Product
9-valent human papillomavirus (HPV9) vaccine
Description

This protocol will use tree-based scan statistics for the following objectives:

  1. To assess the safety of HPV9 vaccine in females and males ages 9 through 26 years, using the conditional self-controlled tree-temporal scan statistic, evaluating thousands of potential adverse events
  2. To conduct an initial evaluation of any alerts detected, using clinical judgment to review summary statistics and electronically generated claims profiles of the patients contributing to the alert

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.

Additional Details
FDA Center
CBER
Time Period
2006 - 2015
Study Type
Protocol/Surveillance Plan
Assessment Type
Safety Analyses
Population / Cohort
All individuals 9-26 years of age
Data Sources
Sentinel Distributed Database (SDD)
Workgroup Leader(s)

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

Workgroup Members

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