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Sponsored by: |
MedImmune LLC |
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Information provided by: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT00677820 |
This study is designed to verify the safety of the FluMist intranasal vaccine using 3 new strains predicted by the CDC to be prevalent during this year's flu season.
Condition | Intervention | Phase |
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Influenza |
Biological: FluMist Biological: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, 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 Trivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults |
Estimated Enrollment: | 300 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
treatment with FluMist
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Biological: FluMist
Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 ml of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10:7 FFU (fluorescent focus units) of each of three cold-adapted, attenuated, 6:2 reassortant influenza strains A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006.
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2: Placebo Comparator
treatment with placebo
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Biological: Placebo
Placebo is supplied in intranasal sprayers containing 0.5 ml of sucrose-phosphate buffer.
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The objective of this study is to assess the safety of a trivalent influenza virus vaccine containing three new 6:2 reassortants in healthy adults prior to the release of the trivalent vaccine (FluMist) containing them.
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 | |
Austin, Texas, United States, 78752 |
Study Director: | Raymond Mallory, MD | MedImmune LLC |
Responsible Party: | MedImmune ( Rayburn Mallory M.D. ) |
Study ID Numbers: | MI-MA182 |
Study First Received: | May 13, 2008 |
Last Updated: | September 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00677820 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Influenza FluMist vaccine prevention trivalent |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Influenza, Human Healthy Orthomyxoviridae Infections |
RNA Virus Infections |