Tabs
FDA Center:
CBER
Time Period:
2010 - 2011
Study Type:
Protocol/Surveillance Plan
Assessment Type:
Safety Analyses
HOI Study Type:
Validations Supported by Traditional Medical Chart Review
Population / Cohort:
All children 6 - 59 months of age
Data Sources:
Mini-Sentinel Distributed Database (MSDD) and immunization registries in Florida, Michigan, Minnesota, New York City, New York State, Pennsylvania, Virginia, and Wisconsin
Workgroup Leader(s):
Alison Kawai, ScD; Grace Lee, MD, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Workgroup Members:
Martin Kulldorff, PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
David Martin, MD, MPH; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD
Cheryl McMahill-Walraven, PhD, MSW; Aetna: Aetna Informatics, Blue Bell, PA
Mano Selvan, PhD, Comprehensive Health Insights, Humana, Louisville, KY
Nandini Selvam, PhD, MPH; HealthCore, Inc., Alexandria, VA