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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01395082
Other study ID # H-406-003
Secondary ID U1111-1120-1721
Status Completed
Phase
First received
Last updated
Start date April 2011
Est. completion date February 4, 2019

Study information

Verified date March 2024
Source Emergent BioSolutions
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 24
Est. completion date February 4, 2019
Est. primary completion date February 4, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 17 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Emergent BioSolutions

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other 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 2 years after enrollment or after the last symptoms or positive findings
Primary 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
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