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ACAM2000® Myopericarditis Registry

This study is currently recruiting participants.
Verified January 2013 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01395082
First received: July 13, 2011
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Objectives:

  • To document the natural history of confirmed, probable, suspected, and subclinical myocarditis and pericarditis (myopericarditis) following ACAM2000® vaccination.
  • To look for potential predictive factors for the prognosis of myopericarditis following ACAM2000® vaccination.

Condition
Myocarditis
Pericarditis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ACAM2000® Myopericarditis Registry

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]
  • 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 ]

Estimated Enrollment: 150
Study Start Date: April 2011
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Entire registry group
Participants with potential myopericarditis cases referred to the Registry

Detailed 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 up for up to 5 years.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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:

  • Subjects not meeting one of the case definitions for myopericarditis will not be entered into the Registry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01395082

Contacts
Contact: Public Registry Sanofi Pasteur RegistryContactUs@sanofipasteur.com

Locations
United States, California
Recruiting
San Diego, California, United States, 92106
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01395082     History of Changes
Other Study ID Numbers: H-406-003, U1111-1120-1721
Study First Received: July 13, 2011
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Myocarditis
Pericarditis
Vaccinia virus
ACAM2000®
Smallpox vaccine

Additional relevant MeSH terms:
Myocarditis
Pericarditis
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013