ACAM2000® Myopericarditis Registry
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|