Overview

This trial is active, not recruiting.

Conditions myocarditis, pericarditis
Sponsor Sanofi Pasteur, a Sanofi Company
Start date April 2011
End date April 2016
Trial size 200 participants
Trial identifier NCT01395082, H-406-003, U1111-1120-1721

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Participants with potential myopericarditis cases referred to the Registry

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title ACAM2000® Myopericarditis Registry
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).
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Sanofi.