This study evaluates the safety, tolerability and immunogenicity of IL-YANG quadrivalent vaccine versus IL-YANG trivalent vaccine after a single intramuscular administration in healthy Korean males and females 19 to \< 65 years of age.
This is a randomized, double-blind, active-controlled, phase I/Ⅱa clinical trial. During the Part A phase, all safety data collected from the 12 subjects enrolled in the Part A phase will be analyzed to determine the safety and tolerability of the investigational product, which should include any solicited and unsolicited adverse drug reactions occurring for the first 7 days after vaccination and any adverse events occurring for 28 days after vaccination. Antibody titer test will be also performed to evaluate the efficacy (immunogenicity) of the investigational product. During the Part B phase, a total of 72 subjects will be enrolled, and all safety data (including all adverse events) and immunogenicity data will be analyzed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
Seroconversion Rate
Percentage of subjects achieving seroconversion\* for HI antibody after vaccination
Time frame: 28 days
Seroprotection Rate
Percentage of subjects achieving seroprotection\* for HI antibody after vaccination
Time frame: 28 days
GMR
Geometric Mean Ratio of post vaccination HI geometric mean titers
Time frame: 28 days
GMT
Geometric Mean Titer of post vaccination HI geometric mean titers
Time frame: 28 days
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