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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01395082
|Contact: Public Registry Sanofi Pasteur||RegistryContactUs@sanofipasteur.com|
|United States, California|
|San Diego, California, United States, 92106|
|Study Director:||Medical Director||Sanofi Pasteur Inc.|