Accessing the Freshest Feasible Data for Conducting Active Influenza Vaccine Safety Surveillance (PRISM)

Basic Details
Date Posted
Monday, April 6, 2015
Status
Complete
Medical Product
influenza vaccine
Health Outcome(s)
anaphylaxis
febrile seizure
Description

Project to establish and assess an active surveillance system for seasonal influenza vaccines. Protocol-based assessments use study designs and analysis plans customized for the product-outcome pairs being assessed.

This protocol was posted for public comment from August 2, 2013 through August 16, 2013. The public comment period is now closed. Revised versions of the protocol were approved for implementation by FDA on September 10, 2013, and December 31, 2013. A log of changes is included in the most recently revised protocol (v3.0).

Additional Details
FDA Center
CBER
Study Type
Protocol/Surveillance Plan
Assessment Type
Safety Analyses
Population / Cohort
All children 6-59 months of age
Data Sources
Mini-Sentinel Distributed Database (MSDD) and immunization registries in Florida, Indiana, Michigan, Minnesota, New York City, New York State, Pennsylvania, Virginia, and Wisconsin
Workgroup Leader(s)

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

Sukhminder Sandhu, PhD, MPH, MS; Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD

Workgroup Members

Grace M. Lee, MD, MPH; Ruihua Yin, MS; Robert Jin, MS; David Cole, BM; Lauren Zichittella, MS; Alison Tse Kawai, ScD; Martin Kulldorff, PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Michael Nguyen, MD; Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD

Cheryl N McMahill-Walraven, PhD, MSW; Aetna Data Science, Aetna, Blue Bell, PA 

Mano S. Selvan, PhD; Comprehensive Health Insights, Humana Inc., Louisville, KY

Nandini Selvam, PhD, MPH; Government & Academic Research, HealthCore, Alexandria, VA