ACAM2000® Myopericarditis Registry
- Conditions
- MyocarditisPericarditis
- Registration Number
- NCT01395082
- Lead Sponsor
- Emergent BioSolutions
- Brief Summary
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.
Primary Objective:
- 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.
- Detailed 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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.
- Individuals not meeting at least one of the case definitions for myopericarditis will not be entered into the Registry.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of confirmed, probable, suspected, and subclinical cases of myopericarditis, categorized by time since vaccination 2 years after enrollment or after the last symptoms or positive findings
- Secondary Outcome Measures
Name Time Method