Tabs
FDA Center:
CBER
Time Period:
2006 - 2011
Study Type:
Protocol/Surveillance Plan
Assessment Type:
Safety Analyses
HOI Study Type:
Validations Supported by Traditional Medical Chart Review
Population / Cohort:
All females 9-26 years of age
Data Sources:
Mini-Sentinel Distributed Dataset (MSDD); immunization registry data from any of the nine participating registries (also known as immunization information systems (IIS))
Workgroup Leader(s):
Michael D. Nguyen, MD; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD
Sharon K. Greene, PhD, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Workgroup Members:
W. Katherine Yih, PhD, MPH; Martin Kulldorff, PhD; Tracy A. Lieu, MD, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
David B. Martin, MD, MPH; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD
Nandini Selvam, PhD, MPH; HealthCore Inc., Alexandria, VA
Vinit P. Nair BPharm, MS, RPh; Comprehensive Health Insights, Humana Inc., Louisville, KY
Cheryl N. McMahill-Walraven, PhD, MSW; Aetna Informatics, Aetna, Inc., Blue Bell, PA