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Safety Surveillance Study of ACAM2000® Vaccinia Vaccine

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00927719
First Posted: June 25, 2009
Last Update Posted: June 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
June 24, 2009
June 25, 2009
June 29, 2017
December 2008
December 2017   (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 ]
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: Retrospective
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.
 
Active, not recruiting
200000
December 2017
December 2017   (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 :

Sexes Eligible for Study: All
17 Years and older   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00927719
H-406-005
No
Not Provided
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available at Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Pasteur Inc
Sanofi
June 2017