Clinical Trial: Safety Study of GBS Following Menactra Meningococcal Vaccination
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Risk of Guillain-Barré Syndrome Following Meningococcal Conjugate (MCV4) Vaccination
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.
Detailed Summary:
Through a partnership that uses the data and other resources of three national and two regional health plans and insurers, 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 (ages 11-21 years of age) over the 42-month period of March 1, 2005 to August 31, 2008. This collaboration has several features of a distributed data network, and so provides an instructive example of the feasibility of large scale population-based post-market evidence development.
Participants include five research organizations that are either part of, or closely affiliated with, a health plan or insurer: HealthCore Inc. (affiliated with WellPoint), Highmark Blue Cross Blue Shield of Pennsylvania, i3 Drug Safety, Aetna, Inc., and Kaiser Permanente Center for Health Research of Hawaii. There is a coordinating center at the Harvard Medical School Department of Ambulatory Care and Prevention at Harvard Pilgrim Health Care.
The organizations provide coverage for approximately 80 million individuals (all ages), of whom the information for approximately 50 million will be available for analysis. Each organization provides scientific, informatics, and management expertise regarding its own population and data, and the overall design and conduct of the study.
This retrospective study uses a hybrid design with three analytic components: 1) characterization of the entire cohort with regard to demographics, eligible time under observation, immunization status, incidence rates of GBS during various categories of person time (never immunized, before immunization, during the 42 days after immunization, etc.), and comorbidities and other covariates, 2) a nested case-c
Sponsor: Harvard Pilgrim Health Care
Current Primary Outcome: Guillain-Barré syndrome (GBS), verified through neurologist review of medical records [ Time Frame: within 42 days following vaccination ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Clinical presentation and severity of GBS [ Time Frame: following vaccination ]
Original Secondary Outcome: Same as current
Information By: Harvard Pilgrim Health Care
Dates:
Date Received: December 17, 2007
Date Started: March 2005
Date Completion:
Last Updated: March 15, 2017
Last Verified: December 2007
