Safety Surveillance Study of ACAM2000® Vaccinia Vaccine
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 17 - Any |
| Updated: | 2/2/2019 |
| Start Date: | December 2008 |
| End Date: | December 31, 2017 |
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.
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.
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.
Inclusion Criteria :
- Male and female military personnel >= 17 years of age.
- Have received the ACAM2000® smallpox vaccine.
Exclusion Criteria :
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