Intussusception Risk After Rotavirus Vaccination in U.S. Infants (PRISM)

Project Title Intussusception Risk After Rotavirus Vaccination in U.S. Infants (PRISM)
Date Posted
Monday, February 3, 2014
Status
Complete
Deliverables
Related Links
Description

Protocol-based retrospective assessment of the risk of intussusception associated with rotavirus vaccination coupled with a medical chart review of cases identified by a diagnosis and procedure code-based algorithm in electronic healthcare databases.

The information contained in this report is associated with an FDA Safety Communication issued on June 13, 2013. Click here to see the Safety Communication. Click here to see the related Questions and Answers page.

This protocol was initially posted on the Mini-Sentinel website in October 2011. A revised version was approved for implementation by FDA on April 23, 2012. A log of changes is included in the revised protocol.

Medical Product
RotaTeq
Rotarix
rotavirus vaccine
Health Outcome
intussusception
Population / Cohort
All infants 5 - 36.9 weeks of age
Time Period
2004 - 2011
Assessment Type
Safety Analyses
Study Type
Protocol/Surveillance Plan
Workgroup Leader(s)

W. Katherine Yih PhD, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Michael Nguyen MD; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

Workgroup Members

Tracy Lieu MD, MPH; Division of Research, Kaiser Permanente Northern California, Oakland, CA

Martin Kulldorff PhD; Richard Platt MD, MSc; Grace M. Lee MD, MPH; 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 Inc., Louisville, KY;

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

Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CBER