This is a phase 2A randomized, double blind, placebo controlled trial to evaluate the safety and immunogenicity of a trivalent seasonal influenza virus-like particle (VLP) vaccine (recombinant) in healthy adults.
The primary study objectives are: * To assess the tolerability and safety of the Influenza VLP Vaccine * To assess the immunogenicity of the Influenza VLP Vaccine as measured by hemagglutination inhibition (HAI) antibody titers to each of the component viral strains
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
221
phosphate-buffered saline (PBS)
University Clinical Research, Inc.
Pembroke Pines, Florida, United States
SNBL Clinical Pharmacology Center
Baltimore, Maryland, United States
To assess the tolerability and safety of the Influenza VLP Vaccine
Time frame: 10 days, 6 months
The Influenza VLP Vaccine will be immunogenic
Time frame: 22 days
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