Safety Study of GBS Following Menactra Meningococcal Vaccination
Recruitment status was Active, not recruiting
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Risk of Guillain-Barré Syndrome Following Meningococcal Conjugate (MCV4) Vaccination|
- Guillain-Barré syndrome (GBS), verified through neurologist review of medical records [ Time Frame: within 42 days following vaccination ] [ Designated as safety issue: Yes ]
- Clinical presentation and severity of GBS [ Time Frame: following vaccination ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2005|
|Estimated Study Completion Date:||August 2008|
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.
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.
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.
|United States, Delaware|
|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|
|Blue Bell, Pennsylvania, United States|
|Highmark Blue Cross Blue Shield|
|Pittsburgh, Pennsylvania, United States|
|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|