The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated Split Influenza Vaccine (IL-YANG Quadrivalent Seasonal Influenza Vaccine) in healthy infants from 6 months to under 3 years of age(≥ 6 months and \< 3 years)
The study is an Randomized, Double-blind, Active controlled Phase III study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
245
Teratect Prefilled Syringe Inj. 0.5mL
Fluarix Tetra Pre-filled Syringe 0.5mL
Korea University ANSAN Hospital
Ansan-si, Gyeonnggi-do, South Korea
NOT_YET_RECRUITINGThe Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon-si, Gyeonnggi-do, South Korea
RECRUITINGSeroconversion rate against Hemagglutination Inhibition(HI) antibody
Seroconversion rate(a lower bound of 95 CI) ≥ 40%
Time frame: Up to Day28(+7) after the last vaccination
Seroprotection rate against Hemagglutination
Seroprotection rate(a lower bound of 95 CI) ≥ 70%
Time frame: Up to Day28(+7) after the last vaccination
Geometric Mean Titer(GMT)
GMT of HI Antibody Titer Before Vaccination and After Vaccination
Time frame: Up to Day28(+7) after the last vaccination
Geometric Mean Ratio(GMR)
GMR of HI Antibody Titer Before Vaccination and After Vaccination
Time frame: Up to Day28(+7) after the last vaccination
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