Safety Surveillance Study of ACAM2000® Vaccinia Vaccine

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00927719
First received: June 24, 2009
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

This is an enhanced safety surveillance study that will occur within the military Service Member population.

Primary Objective:

  • To evaluate the rates of suspected, probable, and confirmed myocarditis and/or pericarditis in temporal association with ACAM2000® vaccination.

Secondary Objectives:

  • To evaluate the rates of cardiovascular adverse events in temporal association with ACAM2000® vaccination.
  • To evaluate the rates of neurological adverse events in temporal association with ACAM2000® vaccination.

Condition Intervention Phase
Smallpox
Biological: ACAM2000® smallpox vaccine
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Phase IV Enhanced Safety Surveillance Study of ACAM2000® in Military Personnel

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To provide information concerning the safety following vaccination with ACAM2000® vaccinia vaccine [ Time Frame: Entire study duration ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200000
Study Start Date: December 2008
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ACAM2000® vaccinia vaccine Cohort
Participants had received ACAM2000®, vaccinia virus Smallpox vaccine.
Biological: ACAM2000® smallpox vaccine
Previous vaccination, no vaccine is administered in this study.
Other Name: ACAM2000®

Detailed Description:

The Armed Forces Health Surveillance Activity (AFHSA) will perform comprehensive health surveillance through the operation of the Defense Medical Surveillance System (DMSS). Demographic and medical information gathered within monthly reports from the DMSS will be collected from approximately 100,000 to 200,000 military Service Members who received the ACAM2000® smallpox vaccine.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants that had received ACAM2000®, vaccinia virus Smallpox vaccine.

Criteria

Inclusion Criteria :

  • Male and female military personnel >= 17 years of age.
  • Have received the ACAM2000® smallpox vaccine.

Exclusion Criteria :

  • Not applicable.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927719

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

Locations
United States, California
Recruiting
Twentynine Palms, California, United States, 92278
United States, Kentucky
Recruiting
Ft Campbell, Kentucky, United States, 42223
United States, Texas
Recruiting
Ft. Bliss, Texas, United States, 79906
Recruiting
Ft. Hood, Texas, United States, 76544
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00927719     History of Changes
Other Study ID Numbers: H-406-005
Study First Received: June 24, 2009
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Smallpox
Smallpox Vaccine
Vaccinia virus
Military

Additional relevant MeSH terms:
Smallpox
DNA Virus Infections
Poxviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014