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Clinical Trials/NCT00189943
NCT00189943CompletedPhase 1

Phase I Study on Safety, Tolerability and Immunogenicity of the MVA-BN Vaccine Administered to Healthy Subjects

Bavarian Nordic1 site in 1 country90 target enrollmentStarted: April 1, 2001Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
90
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 administration in vaccinia-naive and vaccinated healthy volunteers

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double

Eligibility Criteria

Ages
20 Years to 55 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Healthy male subjects, aged 20 - 55 years
  • •Signed informed consent

Exclusion Criteria

  • •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)

Investigators

Sponsor Class
Industry

Study Sites (1)

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