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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00258947 |
Primary Objective:
To estimate the smallpox vaccination take rate in healthy young adults not previously vaccinated with a smallpox vaccine.
Secondary Objectives:
To describe antibody response to vaccination and evaluate the take for each subject at various timepoints for each batch and pooled batches and to evaluate local signs, symptoms, and overall safety in healthy young adults not previously vaccinated with a smallpox vaccine.
Condition | Intervention | Phase |
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Smallpox Poxvirus Infection |
Biological: Smallpox vaccine, LISTER strain, from chick embryo cells |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Ages Eligible for Study: | 18 Years to 25 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Sanofi Pasteur Inc ( Medical Director ) |
Study ID Numbers: | VVL04 |
Study First Received: | November 24, 2005 |
Last Updated: | September 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00258947 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Smallpox Orthopoxvirus Poxvirus |
Vaccina Virus LISTER Strain Bioterrorism |
Virus Diseases Smallpox Poxviridae Infections |
Poxviridae disease DNA Virus Infections Healthy |
Infection |