Safety Surveillance Study of ACAM2000® Vaccinia Vaccine
This is an enhanced safety surveillance study that will occur within the military Service Member population.
- To evaluate the rates of suspected, probable, and confirmed myocarditis and/or pericarditis in temporal association with ACAM2000® vaccination.
- 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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Phase IV Enhanced Safety Surveillance Study of ACAM2000® in Military Personnel|
- To provide information concerning the safety following vaccination with ACAM2000® vaccinia vaccine [ Time Frame: Entire study duration ] [ Designated as safety issue: Yes ]
|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)|
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®
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00927719
|Contact: Public Registry Sanofi Pasteur||RegistryContactUs@sanofipasteur.com|
|United States, California|
|Twentynine Palms, California, United States, 92278|
|United States, Kentucky|
|Ft Campbell, Kentucky, United States, 42223|
|United States, Texas|
|Ft. Bliss, Texas, United States, 79906|
|Ft. Hood, Texas, United States, 76544|
|Study Director:||Medical Director||Sanofi Pasteur Inc|