Influenza, Human Clinical Trial
Official title:
A Randomized, Double-blind, Active Comparator, Phase I/Ⅱa Clinical Trial to Assess the Safety and Immunogenicity of the 'IL-YANG Flu Vaccine Quadrivalent Inj.' in Healthy Korean Adult Subjects
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.
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