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

Project Title Accessing the Freshest Feasible Data for Conducting Active Influenza Vaccine Safety Surveillance (PRISM)
Date Posted
Monday, April 6, 2015
Status
Complete
Deliverables
Related Links
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).

Medical Product
influenza vaccine
Health Outcome
anaphylaxis
febrile seizure
Population / Cohort
All children 6-59 months of age
Assessment Type
Safety Analyses
Study Type
Protocol/Surveillance Plan
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

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
FDA Center
CBER