Smallpox
Conditions
Keywords
Smallpox, Smallpox Vaccine, Vaccinia virus, Military
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.
Interventions
BIOLOGICALACAM2000® smallpox vaccine
Previous vaccination, no vaccine is administered in this study.
Sponsors
Emergent BioSolutions
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
: * Male and female military personnel \>= 17 years of age. * Have received the ACAM2000® smallpox vaccine.
Exclusion criteria
: * Not applicable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To provide information concerning the safety following vaccination with ACAM2000® vaccinia vaccine | Entire study duration |
Countries
United States
Outcome results
None listed