Study To Evaluate the Safety of Bivalent Vaccine
To assess the safety of a bivalent vaccine of two new influenza virus reassortants in healthy adults prior to the release of the trivalent vaccine (FluMist) containing them.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of a Bivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults|
- The primary endpoint of this study is fever (Study Days 0-7), defined as oral temperature of at least 101°F.
- Secondary endpoints of the study include other reported REs and AEs that occur within 7 days after vaccination (Study Days 0-7) and all REs and AEs that occur within 14 days after vaccination (Study Days 0-14).
|Study Start Date:||June 2006|
|Estimated Study Completion Date:||December 2006|
This prospective, randomized, double blind, placebo-controlled release study will enroll approximately 300 healthy adults 18-49 years of age. Eligible subjects will be randomly assigned in a 4:1 fashion to receive a single dose of bivalent vaccine or placebo by intranasal spray. This study will be conducted at multiple sites in the United States. Randomization will be stratified by site.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00325481
|United States, Florida|
|Radiant Research, Daytona Beach|
|Daytona Beach, Florida, United States, 32114|
|United States, Oregon|
|Portland, Oregon, United States, 97239|
|United States, Texas|
|Heathcare Discoveries, Inc.|
|San Antonio, Texas, United States, 78229|
|Study Director:||Maria Allende, M.D.||MedImmune LLC|