ACAM2000® Myopericarditis Registry
The purpose of this registry is to study the natural history of vaccination-related myocarditis and pericarditis and to assess possible risk factors for these conditions.
- To document the natural history of confirmed, probable, suspected, and subclinical myocarditis and pericarditis (myopericarditis) following ACAM2000® vaccination.
Other Pre-defined Objective:
- To look for potential predictive factors for the prognosis of myopericarditis following ACAM2000® vaccination.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||ACAM2000® Myopericarditis Registry|
- The number of confirmed, probable, suspected, and subclinical cases of myopericarditis, categorized by time since vaccination [ Time Frame: 2 years after enrollment or after the last symptoms or positive findings ] [ Designated as safety issue: No ]
- The natural history of myopericarditis in terms of time to resolution or change in status of myopericarditis and the pattern of changes in status of myopericarditis [ Time Frame: 2 years after enrollment or after the last symptoms or positive findings ] [ Designated as safety issue: No ]
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||November 2016|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Entire registry group
Participants with potential myopericarditis cases referred to the Registry
All participants will have received previous vaccination with ACAM2000 but will not receive any vaccination as part of the registry. All participants enrolled in the registry will be followed for 2 up to 5 years (depending on whether there are persisting signs and symptoms of myopericarditis).
|Contact: Public Registry Sanofi Pasteur||RegistryContactUs@sanofipasteur.com|
|United States, California|
|San Diego, California, United States, 92106|
|Study Director:||Medical Director||Sanofi Pasteur Inc.|