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Safety Study of GBS Following Menactra Meningococcal Vaccination

2014-08-27 03:34:27 | BioPortfolio

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.

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Conditions

Guillain-Barre Syndrome

Location

HealthCore, Inc.
Wilmington
Delaware
United States
19801

Status

Active, not recruiting

Source

Harvard Pilgrim Health Care

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:34:27-0400

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Medical and Biotech [MESH] Definitions

One of the SEROTONIN UPTAKE INHIBITORS formerly used for depression but was withdrawn worldwide in September 1983 because of the risk of GUILLAIN-BARRE SYNDROME associated with its use. (From Martindale, The Extra Pharmacopoeia, 29th ed, p385)

A viral disease transmitted by the bite of AEDES mosquitoes infected with ZIKA VIRUS. Its mild DENGUE-like symptoms include fever, rash, headaches and ARTHRALGIA. The viral infection during pregnancy, however, may be associated with other neurological and autoimmune complications (e.g., GUILLAIN-BARRE SYNDROME; and MICROCEPHALY).

A variant of the GUILLAIN-BARRE SYNDROME characterized by the acute onset of oculomotor dysfunction, ataxia, and loss of deep tendon reflexes with relative sparing of strength in the extremities and trunk. The ataxia is produced by peripheral sensory nerve dysfunction and not by cerebellar injury. Facial weakness and sensory loss may also occur. The process is mediated by autoantibodies directed against a component of myelin found in peripheral nerves. (Adams et al., Principles of Neurology, 6th ed, p1313; Neurology 1987 Sep;37(9):1493-8)

Disorders caused by cellular or humoral immune responses primarily directed towards nervous system autoantigens. The immune response may be directed towards specific tissue components (e.g., myelin) and may be limited to the central nervous system (e.g., MULTIPLE SCLEROSIS) or the peripheral nervous system (e.g., GUILLAIN-BARRE SYNDROME).

Experimental animal models for human AUTOIMMUNE DISEASES OF THE NERVOUS SYSTEM. They include GUILLAIN-BARRE SYNDROME (see NEURITIS, AUTOIMMUNE, EXPERIMENTAL); MYASTHENIA GRAVIS (see MYASTHENIA GRAVIS, AUTOIMMUNE, EXPERIMENTAL); and MULTIPLE SCLEROSIS (see ENCEPHALOMYELITIS, AUTOIMMUNE, EXPERIMENTAL).

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