Influenza Vaccines and Febrile Seizures in the 2013-2014 and 2014-2015 Influenza Seasons

Basic Details
Date Posted
Friday, November 10, 2017
Status
Complete
Medical Product
influenza vaccine
Prevnar 13
Health Outcome(s)
febrile seizure
Description

This project was a protocol-based assessment. Evidence on the risk of febrile seizures (FS) after vaccination with inactivated vaccine (IIV) and 13-valent pneumococcal conjugate vaccine (PCV13) is mixed. Among children 6-23 months, we examined the risk of FS following IIV and PCV13 during the 2013-14 and 2014-15 influenza seasons, for which vaccine virus strains were the same.

The Mini-Sentinel Operations Center posted this protocol for public comment from September 11, 2015 through September 25, 2015.  A revised version was approved for implementation by FDA on July 22, 2016. A log of changes is included in the revised protocol (v2).

Additional Details
FDA Center
CBER
Time Period
2013 - 2015
Study Type
Protocol/Surveillance Plan
Assessment Type
Safety Analyses
Population / Cohort
All children 6 - 23 months of age
Workgroup Leader(s)

Meghan Baker, MD, ScD; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA

Christopher Jankosky, MD; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

Workgroup Members

Noelle Cocoros, DSc, MPH; Katherine Yih, PhD, MPH; Alison Kawai, ScD; Lingling Li, PhD; Grace M. Lee, MD, MPH; David Cole, BM; Lauren Zichittella, MS; Sandra Feibelmann, MPH; Diana Santiago, MSPH; Megan Reidy, MPH; Hana Lipowicz, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

David Menschik, MD, MPH; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

Cheryl N. McMahill-Walraven, PhD, MSW; Aetna: Aetna Informatics, Blue Bell, PA

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

Nandini Selvam, PhD, MPH; HealthCore, Inc., Alexandria, VA

Nancy Lin, ScD; OptumInsight Inc., Waltham, MA