A Phase 1 interventional study of MVA (smallpox vaccine) in Smallpox and Atopic Dermatitis, sponsored by Sanofi Pasteur, a Sanofi Company. Withdrawn at 3 sites in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-22.
Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 1, Interventional, and Prevention
purpose of this study is to assess the safety and immunogenicity of two MVA smallpox vaccine injections in healthy adults that are 18-35 years of age with a history of mild to moderate Atopic Dermatitis.
This is a randomized, double-blind, placebo-controlled study. subjects will be randomized to receive investigational vaccine or placebo at a ratio of 3.5:1, MVA3000 to placebo. All subjects will undergo a screening period, a treatment/observation period during which all subjects will receive injections on study day 0 and study day 28 of investigational vaccine or placebo. The clinical observation period will be completed at day 56. A visit will occur at approximately 3 months after the second study injection (study day 118) for additional blood collection and a review of the subject's health status. Follow-up will be obtained via telephone contacts approximately 6 months after the end of the second injection during the treatment/observation period.
73 studies on the registry are indexed under Smallpox; 5 are open to participants now.
Browse Smallpox studies →Sanofi Pasteur, a Sanofi Company is the lead sponsor of 366 studies on the registry; 4 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.
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Exclusion Criteria:
Biological: MVA (smallpox vaccine)
0.5ml of MVA3000 Smallpox vaccine, administered twice separated by 28 days, subcutaneous injections
Also known as: placebo
Safety
Time frame: Study Completion
Immunogenicity
Time frame: Study Completion
This study is withdrawn, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Sanofi Pasteur, a Sanofi Company