Sequential Analysis of Gardasil 9 Safety

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Details

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).

Deliverables (2)

Sequential Analysis of Gardasil 9 Safety Surveillance Plan

Sequential Analysis of Gardasil 9 Safety Final Report

Additional Information

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)

Contributors

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

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Assessments

Sequential Analysis of Gardasil 9 Safety

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