ACAM2000® Myopericarditis Registry
This trial is active, not recruiting.
|Sponsor||Sanofi Pasteur, a Sanofi Company|
|Start date||April 2011|
|End date||April 2016|
|Trial size||200 participants|
|Trial identifier||NCT01395082, H-406-003, U1111-1120-1721|
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.
Participants with potential myopericarditis cases referred to the 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
Male or female participants of any age.
Inclusion Criteria: - Individuals who are current or former members of the active duty, Reserve, or National Guard, from any branch of service - Documented vaccination with ACAM2000® vaccine - Meet one of the case definitions for suspect, probable, confirmed or subclinical myopericarditis. Exclusion Criteria: - Individuals not meeting at least one of the case definitions for myopericarditis will not be entered into the Registry.
|Official title||ACAM2000® Myopericarditis Registry|
|Description||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).|
Call for more information