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.
|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|