Influenza Vaccines and Febrile Seizures (PRISM)

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Details

Basic Details

Date Posted:

Friday, September 18, 2015

Status:

Complete

Medical Product:

influenza vaccine

Health Outcome(s):

febrile seizure

Description:

Protocol-based assessment of the risk of febrile seizures following trivalent inactivated influenza vaccine administered during the 2010-11 influenza season among children ages 6 months through 59 months using a self-controlled risk interval design. Influenza vaccinations and febrile seizure cases were identified in electronic healthcare databases and underwent medical record review. The positive predictive value of three alternative febrile seizures definitions that use ICD9 data was evaluated.

The information contained in this report is associated with an FDA Safety Communication issued on May 16, 2014. Click here to see the Safety Communication.

This protocol was posted for public comment from January 24, 2013 through February 7, 2013. A revised version was approved for implementation by FDA on April 26, 2013. A log of changes is included in the revised protocol (v2.0).

Deliverables (2)

Mini-Sentinel PRISM Influenza Vaccines and Febrile Seizures Protocol

Mini-Sentinel PRISM Influenza Vaccines and Febrile Seizures Report

Additional Information

Additional Details

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

Contributors

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

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Assessments

Influenza Vaccines and Febrile Seizures (PRISM)

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