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Safety Study of GBS Following Menactra Meningococcal Vaccination

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2007 by Harvard Pilgrim Health Care.
Recruitment status was:  Active, not recruiting
Aetna, Inc.
HealthCore, Inc.
Highmark Blue Cross Blue Shield
i3 Drug Safety
Kaiser Permanente
Information provided by:
Harvard Pilgrim Health Care Identifier:
First received: December 17, 2007
Last updated: December 19, 2007
Last verified: December 2007

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.

Guillain-Barre Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Risk of Guillain-Barré Syndrome Following Meningococcal Conjugate (MCV4) Vaccination

Resource links provided by NLM:

Further study details as provided by Harvard Pilgrim Health Care:

Primary Outcome Measures:
  • Guillain-Barré syndrome (GBS), verified through neurologist review of medical records [ Time Frame: within 42 days following vaccination ]

Secondary Outcome Measures:
  • Clinical presentation and severity of GBS [ Time Frame: following vaccination ]

Estimated Enrollment: 6000000
Study Start Date: March 2005
Estimated Study Completion Date: August 2008
11-18 (Primary)
Enrolled members of one of the participating health plans who are ages 11-18 at any time during the study period, March 1, 2005 through August 31, 2008.
19-21 (Secondary)
Enrolled members of one of the participating health plans who are ages 19-21 at any time during the study period, March 1, 2005 through August 31, 2008.

Detailed Description:
We are conducting a multi-site retrospective study of the relationship between immunization with tetravalent meningococcal conjugate vaccine (MCV4) and Guillain-Barré syndrome (GBS) in adolescents over the 42-month period of March 1, 2005 to August 31, 2008. The study will utilize a hybrid cohort/nested case control design to allow direct calculation of incidence rates of GBS using distributed data processing at the site level, and an efficient pooled multivariate analysis of the time dependent risk of GBS following MCV4 vaccination. The study cohort will be assembled from health plan members enrolled at selected health plans throughout the United States. Cases and matched controls will be identified using administrative data, and case validation and collection of information on predisposing factors prior to GBS onset will be performed by medical record review. A conditional logistic regression model will be used to account for the matching, with days since vaccination with MCV4 the main covariate of interest. As an additional assessment of the primary hypothesis, a case-series analysis using the approach described by Farrington for vaccine safety studies will be performed to account for unmeasured confounders that may be associated with vaccination status.

Ages Eligible for Study:   11 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The primary study population will include adolescent health plan members 11-<19 years of age. A secondary cohort will include members 19-<22 years of age. Older adolescents are excluded from the primary cohort because an unknown proportion of immunizations to older individuals may be provided by colleges or other out-of-plan providers, and not be identifiable in health plan records.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00575653

United States, Delaware
HealthCore, Inc.
Wilmington, Delaware, United States, 19801
United States, Hawaii
Kaiser Permanente Center for Health Research Hawaii
Honolulu, Hawaii, United States, 96817
United States, Massachusetts
Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care
Boston, Massachusetts, United States, 02215
i3 Drug Safety
Waltham, Massachusetts, United States, 02451
United States, Pennsylvania
Aetna, Inc.
Blue Bell, Pennsylvania, United States
Highmark Blue Cross Blue Shield
Pittsburgh, Pennsylvania, United States
Sponsors and Collaborators
Harvard Pilgrim Health Care
Aetna, Inc.
HealthCore, Inc.
Highmark Blue Cross Blue Shield
i3 Drug Safety
Kaiser Permanente
Principal Investigator: Richard Platt, MD, MS Dept. of Ambulatory Care and Prevention, HMS/HPHC
Study Director: Priscilla Velentgas, PhD Dept. of Ambulatory Care and Prevention, HMS/HPHC
  More Information

Responsible Party: Richard Platt, Professor and Chair, Dept. of Ambulatory Care and Prevention, Harvard Med School/Harvard PHC Identifier: NCT00575653     History of Changes
Other Study ID Numbers: PH000274A 
Study First Received: December 17, 2007
Last Updated: December 19, 2007

Keywords provided by Harvard Pilgrim Health Care:
Guillain-Barre Syndrome
Meningococcal vaccines
Tetravalent Meningococcal Vaccine
Vaccines, Conjugate

Additional relevant MeSH terms:
Guillain-Barre Syndrome
Pathologic Processes
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on February 27, 2017