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
Mini-Sentinel PRISM Rotavirus and Intussusception Protocol
Mini-Sentinel PRISM Rotavirus and Intussusception Report
Related Links
FDA Safety Communication: FDA Approves Required Revised Labeling for RotaTeq Based Final Study Results of a Mini-Sentinel Postlicensure Observational Study of Rotavirus Vaccines and Intussusception
RotaTeq (Rotavirus Vaccine) Questions and Answers
Update: Information on Rotarix- Labeling Revision Pertaining to Intussusception
Findings from a Mini-Sentinel Assessment: Rotavirus Vaccines and Risk of Intussusception
Intussusception Risk after Rotavirus Vaccination in U.S. Infants
Intussusception Algorithm Defined in "Intussusception Risk After Rotavirus Vaccination in U.S. Infants (PRISM)"
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
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