ACAM2000® Myopericarditis Registry

Myocarditis Clinical Trial

Official title:

ACAM2000® Myopericarditis Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01395082
• Other study ID #: H-406-003
• Secondary ID: U1111-1120-1721
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Myocarditis
• Pericarditis

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