Influenza Vaccines and Febrile Seizures (PRISM)

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 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
Related Links
Update: FDA Postlicensure Rapid Immunization Safety Monitoring (PRISM) Study Demonstrates No Statistically Significant Association between Trivalent Inactivated Influenza Vaccine and Febrile Seizures in Children during the 2010-2011 Influenza Season
Febrile Seizures After 2010–2011 Trivalent Inactivated Influenza Vaccine
Validation of Febrile Seizures Identified in the Sentinel Post-Licensure Rapid Immunization Safety Monitoring Program
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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