ACAM2000® Myopericarditis Registry
|ClinicalTrials.gov Identifier: NCT01395082|
Recruitment Status : Active, not recruiting
First Posted : July 15, 2011
Last Update Posted : January 30, 2018
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||ACAM2000® Myopericarditis Registry|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||April 2024|
|Estimated Study Completion Date :||April 2024|
Entire registry group
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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395082
|United States, California|
|San Diego, California, United States, 92106|
|Study Director:||Medical Director||Emergent BioSolutions|