Safety Study of GBS Following Menactra Meningococcal Vaccination
Public ClinicalTrials.gov record NCT00575653. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Risk of Guillain-Barré Syndrome Following Meningococcal Conjugate (MCV4) Vaccination
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00575653
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 6,000,000 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 11 Years to 21 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2005
- Primary completion
- Dec 30, 2009
- Completion
- Dec 30, 2010
- Last update posted
- Mar 15, 2017
2005 – 2010
United States locations
- U.S. sites
- 6
- U.S. states
- 4
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| HealthCore, Inc. | Wilmington | Delaware | 19801 | — |
| Kaiser Permanente Center for Health Research Hawaii | Honolulu | Hawaii | 96817 | — |
| Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care | Boston | Massachusetts | 02215 | — |
| i3 Drug Safety | Waltham | Massachusetts | 02451 | — |
| Aetna, Inc. | Blue Bell | Pennsylvania | — | — |
| Highmark Blue Cross Blue Shield | Pittsburgh | Pennsylvania | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00575653, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 15, 2017 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00575653 live on ClinicalTrials.gov.