Influenza Clinical Trial
Official title:
Safety and Immunogenicity Among Adults of Fluzone®, Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route)
The aim of the study is to evaluate the safety and immunogenicity of the 2011-2012
formulation of Fluzone and Fluzone High-Dose vaccines in participants aged 65 years and
older.
Objectives:
- To describe the safety of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥
65 years of age.
- To describe the immunogenicity of Fluzone vaccine and Fluzone High-Dose vaccine among
adults ≥ 65 years of age.
Historically, the annual safety and immunogenicity study of Fluzone vaccine has been
conducted in the US in support of licenses held by sanofi pasteur in various countries.
Participants will be randomized to receive a dose of either Fluzone® or Fluzone® High-Dose
vaccine and will be followed up for safety and immunogenicity. The duration of participation
in the trial will be approximately 1 month.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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