Safety Study of GBS Following Menactra Meningococcal Vaccination

Completed

Conditions studied: Guillain-Barre Syndrome

In brief

We are conducting a large, record-based study to assess the risk of Guillain-Barré Syndrome (GBS), a serious demyelinating disease, following immunization with the tetravalent meningococcal conjugate vaccine (Menactra) that is currently recommended for all adolescents. The study was requested by CDC and FDA because of an unexpected number of case reports to the CDC's Vaccine Adverse Event Reporting System (VAERS). The study protocol was designed by the investigators, with input from FDA, CDC, and the vaccine's manufacturer, Sanofi-Pasteur. An external advisory board that includes CDC representation, provides input regarding important decisions. The manufacturer is not participating in the conduct of the study and has no control over the analysis or dissemination of results. The study is derived from five large US health plans with a total membership of approximately 50 million over the study time period. America's Health Insurance Plans (AHIP) serves as liaison between the health plans and the Coordinating Center at the Department of Ambulatory Care and Prevention of Harvard Medical School and Harvard Pilgrim Health Care, and is the contracting organization with the health plans.

Key facts

Study ID

NCT00575653

Run by

Harvard Pilgrim Health Care

People needed

6000000

Starts

2005-03-01

Expected to finish

2010-12-31

Last updated by the study team

2017-03-16

Who can join

Age: 11 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Enrolled health plan members for at least 6 months prior to cohort entry
• Enrolled between March 1, 2005 and August 31, 2008
• Birth dates between March 2, 1986 and August 30, 1997 for the primary study cohort
• Birth dates between March 2, 1983 to March 1, 1986 for the secondary cohort

You may not qualify if…

• None

Where it is running

• HealthCore, Inc. — Wilmington, Delaware, United States
• Kaiser Permanente Center for Health Research Hawaii — Honolulu, Hawaii, United States
• Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care — Boston, Massachusetts, United States
• i3 Drug Safety — Waltham, Massachusetts, United States
• Aetna, Inc. — Blue Bell, Pennsylvania, United States
• Highmark Blue Cross Blue Shield — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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