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Health Outcomes Among Individuals Exposed to Medical Products Details

Results from Assessments of Health Outcomes Among Individuals Exposed to Medical Products Search
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Project TitleIntussusception Risk After Rotavirus Vaccination in U.S. Infants (PRISM)
Date Posted 6-14-2013
Project StatusComplete
Assessment TypeProtocol
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 ProductRotavirus vaccines, RotaTeq, Rotarix
Health OutcomeIntussusception
Population / CohortInfants (infants 5-36.9 weeks for chart review)
Time PeriodJan 2004-Jan 2011
Workgroup LeadersW. 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, U.S. Food and Drug Administration, Rockville, MD
Workgroup MembersTracy Lieu, Division of Research, Kaiser Permanente Northern California, Oakland, CA; Martin Kulldorff, PhD, Richard Platt, MD, MSc, and 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, U.S. Food and Drug Administration, Rockville, MD; Cheryl McMahill-Walraven, MSW, PhD, Aetna Inc, Blue Bell, PA; Mano Selvan, PhD, Humana, Louisville, KY; Nandini Selvam, PhD, MPH, HealthCore Inc, Alexandria, VA
Data SourcesMini-Sentinel Data Partners – Aetna, HealthCore, and Humana
Deliverables Protocol: Monitoring for Intussusception after Two Rotavirus Vaccines by the PRISM Program v2.0

Report: Intussusception Risk after Rotavirus Vaccination in U.S. Infants

Related Links FDA Safety Communication — June 13, 2013: FDA Releases Final Study Results of a Mini-Sentinel Postlicensure Observational Study of Rotavirus Vaccines and Intussusception

RotaTeq (Rotavirus Vaccine) Questions and Answers

Brookings Webinar: Findings from a Mini-Sentinel Assessment: Rotavirus Vaccines and Risk of Intussusception
KeywordsPRISM, Center for Biologics Evaluation and Research, CBER, FDA Safety Communication, active surveillance protocol, monitoring vaccine-outcome pairs, validation, rotavirus vaccines, RotaTeq, Rotarix, intussusception, Yih, Nguyen, Lieu, Kulldorff, Platt, Lee, Martin, McMahill-Walraven, Selvan, Selvam

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Page Updated: 2014