| Project Title | Sequential Analysis of Gardasil 9 Safety |
| Date Posted | Wednesday, November 28, 2018 |
| Status | Discontinued |
| Deliverables | |
| Related Links | |
| 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). |
| Medical Product | 9-valent human papillomavirus (HPV9) vaccine |
| Health Outcome | acute disseminated encephalomyelitis (ADEM) acute pericarditis complex regional pain syndrome (CRPS) uveitis |
| Population / Cohort | All individuals 9-26 years of age |
| Assessment Type | Safety Analyses |
| Study Type | Protocol/Surveillance Plan |
| 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 |
| Data Sources | Mini-Sentinel Distributed Database (MSDD) |
| FDA Center | CBER |
