Status and phase
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About
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.
Enrollment
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Volunteers
Inclusion criteria
Exclusion criteria
Note: Concomitant participation in an observational trial (not involving drugs, vaccines, or medical devices) is acceptable.
Primary purpose
Allocation
Interventional model
Masking
2,098 participants in 5 patient groups
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Data sourced from clinicaltrials.gov
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