* To assess the tolerability and safety of a single injection of Influenza VLP Vaccine when administered intramuscularly (IM) at 15 µg and 60 µg HA per each strain. * To assess the immunogenicity of Influenza VLP Vaccine administered at 15 µg and 60 µg HA per strain as measured by hemagglutination inhibition (HAI) antibody titers to each of the component viral strains \[A/Brisbane/59/2007 (H1N1); A/Brisbane/10/2007 (H3N2) and B/Brisbane/60/2008\].
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
467
Single dose; 0.5mL
Trivalent Influenza Vaccine 15ug/strain, commercially licensed
Universtity Clinical Research
Pembroke Pines, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
Brown University
Providence, Rhode Island, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Adverse Events (AEs)
Time frame: 0-21 days
Immunogenicity by HAI
Time frame: 21 Days
Immunogenicity by HAI compared to commercially licensed TIV vaccine
Time frame: 21 days
Immunogenicity Against drifted strains by HAI
Time frame: 21 days
Immunogenicity by neuraminidase activity inhibition (NAI)
Time frame: 21 Days
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Research Across America
Dallas, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States