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NCT00575653 · ClinicalTrials.gov registry record
Safety Study of GBS Following Menactra Meningococcal Vaccination
A clinical trial of Guillain-Barre Syndrome, sponsored by Harvard Pilgrim Health Care.
- Completed
- Registry status
- 6,000,000
- Enrollment target
- 6
- Study locations
NCT00575653: Completed study of Guillain-Barre Syndrome, sponsored by Harvard Pilgrim Health Care.
NCT00575653 is a study of Guillain-Barre Syndrome that has completed, run by Harvard Pilgrim Health Care. The registered enrollment target is 6,000,000 participants. The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00575653, a study of Guillain-Barre Syndrome, has completed, sponsored by Harvard Pilgrim Health Care.
- COMPLETED
- Registry status
- 6,000,000 participants
- Enrollment target
- 6
- Study locations
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 Studied
Study Locations (6)
Massachusetts
- Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care - Boston
- i3 Drug Safety - Waltham
Pennsylvania
- Aetna, Inc. - Blue Bell
- Highmark Blue Cross Blue Shield - Pittsburgh
Delaware
- HealthCore, Inc. - Wilmington
Hawaii
- Kaiser Permanente Center for Health Research Hawaii - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,000,000 participants |
| Start Date | 2005-03 |
| Est. Completion | 2010-12-31 |
What the finished NCT00575653 record still lists
NCT00575653 is an observational study that tracks outcomes without assigning an intervention. Its 6,000,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 1 condition, with Guillain-Barre Syndrome appearing as the primary indexed condition, and to 0 interventions.
NCT00575653 lists 6 locations in 4 states (Massachusetts, Pennsylvania, Delaware).
Frequently Asked Questions
What is clinical trial NCT00575653 about?
NCT00575653 is a clinical study titled "Safety Study of GBS Following Menactra Meningococcal Vaccination". 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...
What is the current status of trial NCT00575653?
This trial is currently completed. The enrollment target is 6,000,000 participants. The study started on 2005-03. Estimated completion is 2010-12-31.
What conditions does trial NCT00575653 study?
This clinical trial studies the following conditions: Guillain-Barre Syndrome.
Who is sponsoring clinical trial NCT00575653?
This trial is sponsored by Harvard Pilgrim Health Care, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00575653 being conducted?
This trial has 6 study locations across Delaware, Hawaii, Massachusetts, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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