Influenza Clinical Trial
Official title:
Lot Consistency, Immunogenicity, and Safety Study of Three Lots of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® Administered Intramuscularly in Adult Subjects Aged 18 to 64 Years
This study is designed to test lot consistency of three different manufacturing lots and to
generate safety and immunogenicity data of the investigational vaccine administered via the
ID route.
Primary Objective:
- To demonstrate lot consistency of the Fluzone ID manufacturing process.
- To provide information concerning the immune response of Fluzone ID.
Secondary Objectives:
Safety
- To describe the safety profile of subjects who receive of Fluzone ID.
Three lots of the investigational Fluzone vaccine with the 2008/2009 Northern Hemisphere formulation will be administered intradermally (ID) using the Becton Dickinson Micro Injection System. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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