The purpose of this study is to determine the immune response of three dose levels of the Quadrivalent VLP vaccine in healthy young (18-49) adults. The study is broken down into four treatment groups. Each group will enroll 100 subjects, for a total of 400 subjects. Groups A-C will receive one of three dose levels of the Quadrivalent VLP vaccine, and Group D will receive a commercially available trivalent influenza vaccine (TIV). The study will also evaluate the safety and tolerability of the Quadrivalent VLP vaccine formulations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
400
Anaheim Clinical Trials
Anaheim, California, United States
Miami Research Associates
Miami, Florida, United States
Johnson County Clin Trials
Lenexa, Kansas, United States
Meridian Clinical Research
Omaha, Nebraska, United States
Immunogenicity of the quadrivalent VLP vaccine using HAI responses.
Derived/calculated endpoints based on: Seroconversion rate (SCR) Seroprotection rate (SPR) Geometric mean titer (GMT) Geometric mean ratio (GMR)
Time frame: Up to 6 months
Safety of three quadrivalent VLP vaccine formulations. adverse events, Medically Attended Events (MAEs), Serious Adverse Events (SAEs), and Significant New medical Conditions (SNMCs)
Number and percentage of subjects with solicited local and systemic adverse events over the seven days post-injections; all adverse events (including adverse changes in clinical laboratory parameters) over 21 days post-injections; and Medically Attended Events (MAEs), Serious Adverse Events (SAEs), and Significant New medical Conditions (SNMCs) through six months.
Time frame: Up to 6 months
Immunogenicity of each quadrivalent VLP vaccine formulation measured by neuraminidase inhibition (NAI)
Derived/calculated endpoints based on: Two fold and four fold increases in NAI titer Geometric mean titer (GMT) Geometric mean ratio (GMR)
Time frame: Up to 6 months
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Clinical Trials of Texas
San Antonio, Texas, United States