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

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Details

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).

Deliverables (2)

Mini-Sentinel PRISM Active Influenza Vaccine Safety Surveillance Report

Mini-Sentinel PRISM Active Influenza Vaccine Safety Surveillance Protocol

Additional Information

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

Contributors

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

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Assessments

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

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