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Sponsored by: |
MedImmune LLC |
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Information provided by: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT00480155 |
To assess the safety of a vaccine in healthy adults prior to the release of the vaccine (FluMist®) containing it.
Condition | Intervention | Phase |
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Healthy |
Biological: Frozen FluMist® Other: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety Study |
Official Title: | A Prospective, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Safety of A Monovalent Vaccine in Healthy Adults |
Enrollment: | 300 |
Study Start Date: | May 2007 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
FluMist
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Biological: Frozen FluMist®
Monovalent vaccine is supplied in intranasal sprayers containing 0.5 mL.
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2: Placebo Comparator
Placebo
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Other: Placebo |
The objective is to assess the safety of a monovalent vaccine of a new 6:2 influenza virus reassortant in healthy adults prior to the release of the trivalent vaccine (FluMist®) containing it.
Ages Eligible for Study: | 18 Years to 49 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Covance Daytona Beach | |
Daytona Beach, Florida, United States, 32117 | |
United States, Oregon | |
Covance Portland | |
Portland, Oregon, United States, 97239 | |
United States, Texas | |
Covance Austin CRU | |
Austin, Texas, United States, 78752 |
Study Director: | Rayburn Mallory, M.D. | MedImmune LLC |
Responsible Party: | MedImmune LLC ( Rayburn Mallory, M.D. ) |
Study ID Numbers: | MI-CP154 |
Study First Received: | May 25, 2007 |
Last Updated: | December 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00480155 |
Health Authority: | United States: Food and Drug Administration |
Healthy |