Status:
COMPLETED
Safety Surveillance Cohort Study of Vaccinia Vaccine (ACAM2000®)
Lead Sponsor:
Emergent BioSolutions
Conditions:
Smallpox
Eligibility:
All Genders
17+ years
Brief Summary
Primary Objectives: * To compare the rates of myopericarditis (subclinical, suspected, probable, or confirmed) in deploying military subjects who received ACAM2000® vaccine to rates among subjects po...
Detailed Description
This is a prospective safety surveillance study in a US military Department of Defense (DoD) population. Military subjects either naive to smallpox immunization and have received ACAM2000® vaccine or ...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Written informed consent obtained prior to the conduct of any study-related procedures.
- Male and Female military personnel positioned for active deployment.
- Participant naïve to previous smallpox vaccination and received the ACAM2000 vaccine (Cohort 1), OR, Participant has not received ACAM2000 vaccine within the prior 3 years, AND is ineligible for current ACAM2000 vaccination either because of recency of prior vaccinia vaccination or for reasons solely attributable to conditions or characteristics of their contacts (such as a healthy soldier who is married to someone with a contraindicated condition) (Cohort 2).
- Exclusion Criteria :
- Subjects judged by the investigator as unlikely to understand the scope of the study and/or unlikely to be able to be compliant with the study procedures and visits.
- Participation in any other studies involving investigational or marketed products within 30 days prior to Visit 1.
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
14108 Patients enrolled
Trial Details
Trial ID
NCT00928577
Start Date
December 1 2008
End Date
December 1 2015
Last Update
April 4 2024
Active Locations (4)
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1
Twentynine Palms, California, United States, 92278
2
Fort Campbell North, Kentucky, United States, 42223
3
Fort Bliss, Texas, United States, 79906
4
Fort Hood, Texas, United States, 76544