Safety Study of GBS Following Menactra Meningococcal Vaccination

NCT00575653 | Completed

• 1 other identifier: PH000274A
• Study Type: observational
• Target: 6,000,000
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Guillain-Barre Syndrome; Meningococcal vaccines; Tetravalent Meningococcal Vaccine; Vaccination; Vaccines; Vaccines, Conjugate

Outcome Measures

Primary Outcomes (1)

• Guillain-Barré syndrome (GBS), verified through neurologist review of medical records

  within 42 days following vaccination

Secondary Outcomes (1)

• Clinical presentation and severity of GBS

  following vaccination

Study Arms (2)

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.

Eligibility Criteria

• Age: 11 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Harvard Pilgrim Health Care: lead
• Aetna, Inc.: collaborator
• HealthCore, Inc.: collaborator
• Highmark Blue Cross Blue Shield: collaborator
• i3 Drug Safety: collaborator
• Kaiser Permanente: collaborator

Study Sites (6)

HealthCore, Inc.

Wilmington, Delaware, 19801, United States

Location

Kaiser Permanente Center for Health Research Hawaii

Honolulu, Hawaii, 96817, United States

Location

Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care

Boston, Massachusetts, 02215, United States

Location

i3 Drug Safety

Waltham, Massachusetts, 02451, United States

Location

Aetna, Inc.

Blue Bell, Pennsylvania, United States

Location

Highmark Blue Cross Blue Shield

Pittsburgh, Pennsylvania, United States

Location

MeSH Terms

Conditions

Guillain-Barre Syndrome

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Platt, MD, MS

  Dept. of Ambulatory Care and Prevention, HMS/HPHC

  PRINCIPAL INVESTIGATOR

• Priscilla Velentgas, PhD

  Dept. of Ambulatory Care and Prevention, HMS/HPHC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 17, 2007
• First Posted: December 18, 2007
• Study Start: March 1, 2005
• Primary Completion: December 31, 2009
• Study Completion: December 31, 2010
• Last Updated: March 16, 2017

Record last verified: 2007-12

Locations

US (6)