Safety Study of GBS Following Menactra Meningococcal Vaccination
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00575653
|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|