View Clinical Trial (Medical Research Study)
A Phase IV Enhanced Safety Surveillance Study of ACAM2000® in Military Personnel
| City: |
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Ft Campbell |
| State: |
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Kentucky |
| Zip Code: |
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42223 |
| Conditions: |
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Smallpox |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria :
- Male and female military personnel >= 17 years of age.
- Have received the ACAM2000® smallpox vaccine.
Exclusion Criteria :
- Not applicable.
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| NCT ID: |
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NCT00927719 |
| Primary Contact: |
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Study Director
Medical Director
Sanofi Pasteur Inc
Public Registry Sanofi Pasteur
Email: RegistryContactUs@sanofipasteur.com
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| Backup Contact: |
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N/A |
| Location Contact: |
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Ft Campbell, Kentucky 42223
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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