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
260
Teratect Prefilled Syringe Inj. 0.5mL
Fluarix Tetra Pre-filled Syringe 0.5mL
Korea University ANSAN Hospital
Ansan-si, Gyeonnggi-do, South Korea
The Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon-si, Gyeonnggi-do, South Korea
Primary immunogenicity endpoints
1. (Seroconversion rate† is) Proportion of subjects achieving seroconversion\* for HI antibody after vaccination with the IP† † Seroconversion rate (SCR) \* Seroconversion: * A pre-vaccination (prior to vaccination with the IP, Day 0) HI antibody titer \<1:10 and a post-vaccination (at Day 28 after the last vaccination with the IP) HI antibody titer ≥1:40 * A pre-vaccination (prior to vaccination with the IP, Day 0) HI antibody titer ≥1:10 and at least a 4-fold increase in post-vaccination (at Day 28 after the last vaccination with the IP) HI antibody titer 2. (Seroprotection rate‡ is) Proportion of subjects achieving seroprotection\*\* for HI antibody after vaccination with the IP‡ ‡ Seroprotection rate (SPR) \*\* Seroprotection: HI antibody titer ≥1:40 at Day 28 after the last vaccination with the IP
Time frame: From a pre-vaccination (prior to vaccination with the IP, Visit1) to a post-vaccination (at Day 28 after the last vaccination with the IP)
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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