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NCT00189943 Clinical Trial

Study on Safety, Tolerability and Immunogenicity of an MVA Vaccine Administered to Healthy Subjects

Smallpox Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00189943
Other study ID # MVA-POX-001
Secondary ID Bavarian Nordic
Status Completed
Phase Phase 1
First received September 12, 2005
Last updated September 12, 2005
Start date April 2001
Est. completion date July 2003

Study information
Verified date September 2005
Source Bavarian Nordic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date July 2003
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 55 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• MVA-BN

Locations
Country Name City State
Germany PharmPlanNet Contract Research GmbH Moenchengladbach

Sponsors (1)
Lead Sponsor Collaborator
Bavarian Nordic

Country where clinical trial is conducted

Germany, 

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