Influenza Clinical Trial
Official title:
Multi-Year Efficacy Study of Fluzone High-Dose Trivalent Vaccine Compared With Fluzone® Vaccine In Adults ≥ 65 Years of Age
The aim of this study is to determine the efficacy of Fluzone High Dose vaccine and that of
Fluzone® vaccine in the elderly.
Primary objective:
To measure the efficacy of the vaccine, defined as the prevention of laboratory-confirmed
influenza caused by viral types/subtypes that are antigenically similar to those contained
in the respective annual vaccine formulations.
Secondary objectives:
- To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone®
vaccine in elderly adults, with respect to laboratory-confirmed influenza illness
caused by any type or subtype of influenza virus.
- To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone®
vaccine in elderly adults, in preventing culture-confirmed influenza illness caused by
viral types/subtypes antigenically similar to those contained in the respective annual
vaccine formulations.
The occurrence of influenza-like illness (ILI) will be determined in elderly participants
vaccinated with either Fluzone High Dose or Fluzone® vaccine.
The presence of influenza virus in the respiratory tract of vaccinated individuals with ILI
will be confirmed by two methods.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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