Safety Surveillance Study of ACAM2000® Vaccinia Vaccine
- Conditions
- Smallpox
- Interventions
- Biological: ACAM2000® smallpox vaccine
- Registration Number
- NCT00927719
- Lead Sponsor
- Emergent BioSolutions
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 897227
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ACAM2000® vaccinia vaccine Cohort ACAM2000® smallpox vaccine Participants had received ACAM2000®, vaccinia virus Smallpox vaccine.
- Primary Outcome Measures
Name Time Method To provide information concerning the safety following vaccination with ACAM2000® vaccinia vaccine Entire study duration
- Secondary Outcome Measures
Name Time Method