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Safety Study of GBS Following Menactra Meningococcal Vaccination

NCT00575653 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 6000000

Last updated 2017-03-16

No results posted yet for this study

Summary

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.

Conditions

  • Guillain-Barre Syndrome

Sponsors & Collaborators

  • Aetna, Inc.

    collaborator INDUSTRY

  • HealthCore, Inc.

    collaborator INDUSTRY

  • Highmark Blue Cross Blue Shield

    collaborator UNKNOWN

  • i3 Drug Safety

    collaborator OTHER

  • Kaiser Permanente

    collaborator OTHER

  • Harvard Pilgrim Health Care

    lead OTHER

Principal Investigators

  • Richard Platt, MD, MS · Dept. of Ambulatory Care and Prevention, HMS/HPHC

  • Priscilla Velentgas, PhD · Dept. of Ambulatory Care and Prevention, HMS/HPHC

Eligibility

Min Age
11 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2009-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00575653 on ClinicalTrials.gov