Status:
COMPLETED
Phase 2 Study of Safety, Tolerability, and Immunogenicity of Three Dose Levels of ACAM3000 Smallpox Vaccine
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Smallpox
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
A phase 2 study to assess the MVA smallpox vaccine in previously vaccinated and vaccine- naive subjects at three dose levels.
Detailed Description
This study will be a randomized, double-blind, placebo-controlled out-patient study conducted in multiple centers in the United States (US). Up to 700 healthy male and female adult subjects 18 to 55 y...
Eligibility Criteria
Inclusion
- subjects must be in good general health, checked on toxicity grading table.
- for previously vaccinated subjects- must be between the ages of 33 and 55 with a previous vaccine more than 10 years ago.
- for vaccine naive subjects- must be between the ages of 18 and 32, and have never been vaccinated for smallpox.
- Female subjects must not be pregnant or lactating.
Exclusion
- Subjects who participated in a "first responder" program.
- any history of immunodeficiency.
- any autoimmune disease
- any history of cardiac disease
- any diagnosed risk factors for ischemic coronary disease
- any history of heart palpitations or abnormalities in cardiac rhythm.
- any current or history of eczema of any description.
- Known allergy to MVA or any of its components, including eggs or egg products.
- morbid obesity
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
590 Patients enrolled
Trial Details
Trial ID
NCT00466245
Start Date
July 1 2005
End Date
June 1 2006
Last Update
January 22 2014
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