Sequential Analysis of Gardasil 9 Safety

Basic Details
Date Posted
Wednesday, November 28, 2018
Status
Discontinued
Medical Product
9-valent human papillomavirus (HPV9) vaccine
Health Outcome(s)
acute disseminated encephalomyelitis (ADEM)
acute pericarditis
complex regional pain syndrome (CRPS)
uveitis
Description

This activity involved developing and implementing a surveillance plan to monitor the safety of Gardasil 9 (HPV9) with respect to four health outcomes, using sequential analysis.

The Sentinel Operations Center posted the protocol for public comment during May 18, 2016, through June 1, 2016. The public comment period is now closed.  Revised versions were approved by FDA on September 27, 2017 and October 4, 2018. A log of changes is included in the final version (v3).

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

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

Adamma Mba-Jonas, MD; Laura Polakowski, MD; Jane Woo, MD; Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Workgroup Members

Meghan Baker, MD, ScD; Carolyn Balsbaugh, MPH; Elizabeth Cavagnaro, MPH; Claudia Coronel-Moreno, MPH; Sandra Feibelmann, MPH; Grace Lee, MD, MPH; Lingling Li, PhD; Ryan Saliga; Lauren Zichittella, MS; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Azadeh Shoaibi, MS, MHS, PhD; Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD