Influenza Clinical Trial
Official title:
Immunogenicity and Safety of Two Dosages of the Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in the Elderly Compared With Standard Fluzone® in Adults and Elderly Subjects.
The present formulations are being developed for further study in the elderly population in
order to generate additional supporting data.
Primary Objective:
To demonstrate non-inferiority of post-vaccination immunogenicity of subjects who received
either 1 of the 2 investigational formulations of a trivalent inactivated vaccine (TIV)
compared to that of the standard Fluzone® in elderly subjects.
Secondary Objectives:
Immunogenicity To describe the immunogenicity in subjects receiving investigational Fluzone
and standard Fluzone®.
Safety:
To evaluate and describe the safety profile of investigational Fluzone in terms of
solicited- and unsolicited adverse events and serious adverse events post-vaccination.
n/a
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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