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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

June 24, 2009
July 15, 2014
December 2008
April 2016   (final data collection date for primary outcome measure)
To provide information concerning the safety following vaccination with ACAM2000® vaccinia vaccine [ Time Frame: Entire study duration ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00927719 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety Surveillance Study of ACAM2000® Vaccinia Vaccine
A Phase IV Enhanced Safety Surveillance Study of ACAM2000® in Military Personnel

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.

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.

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

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

Smallpox
Biological: ACAM2000® smallpox vaccine
Previous vaccination, no vaccine is administered in this study.
Other Name: ACAM2000®
ACAM2000® vaccinia vaccine Cohort
Participants had received ACAM2000®, vaccinia virus Smallpox vaccine.
Intervention: Biological: ACAM2000® smallpox vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200000
September 2016
April 2016   (final data collection date for primary outcome measure)

Inclusion Criteria :

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

Exclusion Criteria :

  • Not applicable.
Both
17 Years and older
Yes
Contact: Public Registry Sanofi Pasteur RegistryContactUs@sanofipasteur.com
United States
 
NCT00927719
H-406-005
No
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Pasteur Inc
Sanofi
July 2014

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