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Sponsors and Collaborators: |
Bavarian Nordic National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | Bavarian Nordic |
ClinicalTrials.gov Identifier: | NCT00316524 |
The primary objective of this study is to evaluate the immune response after a single vaccination of pre-immune subjects compared to two vaccinations in naive subjects.
In addition the study further investigates the safety profile of MVA-BN® in a healthy population compared to placebo.
Condition | Intervention | Phase |
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Smallpox |
Biological: MVA-BN® (IMVAMUNE) Biological: IMVAMUNE |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Partially Randomized, Partially Double-Blind, Placebo-Controlled Phase II Non-Inferiority Study to Evaluate Immunogenicity and Safety of One and Two Doses of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in 18-55 Year Old Healthy Subjects |
Enrollment: | 745 |
Study Start Date: | May 2006 |
Study Completion Date: | August 2007 |
Arms | Assigned Interventions |
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1: Experimental |
Biological: MVA-BN® (IMVAMUNE)
2 immunizations: 1 x 10E8_TCID
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2: Experimental |
Biological: IMVAMUNE
1x 10E8_TCID50, 1x Placebo
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3: Placebo Comparator
2x Placebo
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Biological: IMVAMUNE
2 x Placebo
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4: Experimental
1 immunization: 1x 10E8_TCID50
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Biological: IMVAMUNE
1x 10E8_TCID50
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The study consists of 4 groups, which receive either MVA-BN once, MVA-BN two times, MVA-BN followed by placebo, or two administrations of placebo.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Germany, Bavaria | |
Harrison Clinical Research GmbH | |
Munich, Bavaria, Germany, 80636 |
Principal Investigator: | Frank von Sonnenburg, Prof | Section of International Medicine & Public Health, Department of Infectious Diseases and Tropical Medicine, Ludwig-Maximilians Unviersity Munich |
Responsible Party: | Bavarian Nordic ( Monika Fluer ) |
Study ID Numbers: | POX-MVA-005, DMID 05-0128, EudraCT No. 2005-001781-14 |
Study First Received: | April 19, 2006 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00316524 |
Health Authority: | Germany: Paul-Ehrlich-Institut |
Smallpox Vaccination Prevention |
Virus Diseases Smallpox Poxviridae Infections DNA Virus Infections Healthy |