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OpenTrials
Completed

NCT Number: NCT00189943

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

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

Completed

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Key information

Conditions

Smallpox DNA Virus Infections Infections Poxviridae Infections Virus Diseases

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PharmPlanNet Contract Research GmbH

Mönchengladbach, 41061, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MVA-BN

Biological

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Bavarian Nordic

Industry

Registry information

Official study title

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

Important dates

Study start
2001
Study completion
2003
First posted
Sep 19, 2005
Registry last updated
Sep 19, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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