ACAM2000® Myopericarditis Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01395082
First received: July 13, 2011
Last updated: May 19, 2014
Last verified: May 2014

July 13, 2011
May 19, 2014
April 2011
April 2016   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01395082 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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 ] [ Designated as safety issue: No ]
Not Provided
 
ACAM2000® Myopericarditis Registry
ACAM2000® Myopericarditis Registry

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.

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).

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Eligible participants will have received previous vaccination with ACAM2000® but will not receive any vaccination as part of the registry.

  • Myocarditis
  • Pericarditis
Not Provided
Entire registry group
Participants with potential myopericarditis cases referred to the Registry
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
November 2016
April 2016   (final data collection date for primary outcome measure)

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.
Both
Not Provided
Yes
Contact: Public Registry Sanofi Pasteur RegistryContactUs@sanofipasteur.com
United States
 
NCT01395082
H-406-003, U1111-1120-1721
No
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Pasteur Inc.
Sanofi
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP