NCT01395082

ACAM2000® Myopericarditis Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: Emergent BioSolutions · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Accepted

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).

Conditions

• Myocarditis
• Pericarditis

Timeline

• Start date: 2011-04-01
• Primary completion: 2019-02-04
• Completion: 2019-02-04
• First posted: 2011-07-15
• Last updated: 2024-03-18

Locations

1 site across 1 country: United States