Status:
COMPLETED
Study on Safety, Tolerability and Immunogenicity of an MVA Vaccine Administered to Healthy Subjects
Lead Sponsor:
Bavarian Nordic
Conditions:
Smallpox
Eligibility:
MALE
20-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to collect information on the safety, tolerability and immunogenicity of an investigational smallpox vaccine at different doses and using different routes of administratio...
Eligibility Criteria
Inclusion
- Healthy male subjects, aged 20 - 55 years
- Signed informed consent
Exclusion
- Prior vaccination against smallpox (study part I only)
- Abnormalities suspicious of any underlying disease, detected at routine tests prior to study inclusion.
- Any immune modifying therapy within 4 weeks prior to entry
- Participation in any other investigating drug trial
- Known allergy to a component which may be part of the vaccine
- Allergic reaction or any other severe adverse effects experienced after previous smallpox vaccination (study Part II only)
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
End Date :
July 1 2003
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00189943
Start Date
April 1 2001
End Date
July 1 2003
Last Update
September 19 2005
Active Locations (1)
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1
PharmPlanNet Contract Research GmbH
Mönchengladbach, Germany, 41061