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Trial record 1 of 1 for:    NCT00575653
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Safety Study of GBS Following Menactra Meningococcal Vaccination

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00575653
First Posted: December 18, 2007
Last Update Posted: March 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Aetna, Inc.
HealthCore, Inc.
Highmark Blue Cross Blue Shield
i3 Drug Safety
Kaiser Permanente
Information provided by (Responsible Party):
Richard Platt, Harvard Pilgrim Health Care
  Purpose

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.


Condition
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 Richard Platt, 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 ]

Enrollment: 6000000
Study Start Date: March 2005
Study Completion Date: December 31, 2010
Primary Completion Date: December 31, 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575653


Locations
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
Investigators
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, Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier: NCT00575653     History of Changes
Other Study ID Numbers: PH000274A
First Submitted: December 17, 2007
First Posted: December 18, 2007
Last Update Posted: March 16, 2017
Last Verified: December 2007

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

Additional relevant MeSH terms:
Syndrome
Guillain-Barre Syndrome
Disease
Pathologic Processes
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Polyneuropathies
Autoimmune Diseases
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs