|Project Title||Intussusception Risk After Rotavirus Vaccination in U.S. Infants (PRISM)|
Monday, February 3, 2014
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.
|Population / Cohort||
All infants 5 - 36.9 weeks of age
2004 - 2011
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
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
Mini-Sentinel Distributed Database (MSDD)