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

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Details

Basic Details

Date Posted:

Monday, February 3, 2014

Status:

Complete

Medical Product:

RotaTeq, Rotarix, rotavirus vaccine

Health Outcome(s):

intussusception

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.

Deliverables (2)

Mini-Sentinel PRISM Rotavirus and Intussusception Protocol

Mini-Sentinel PRISM Rotavirus and Intussusception Report

Additional Information

Additional Details

FDA Center:

CBER

Time Period:

2004 - 2011

Study Type:

Protocol/Surveillance Plan

Assessment Type:

Safety Analyses

HOI Study Type:

Validations Supported by Traditional Medical Chart Review

Population / Cohort:

All infants 5 - 36.9 weeks of age

Data Sources:

Mini-Sentinel Distributed Database (MSDD)

Contributors

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

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

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