The purpose of this study is to evaluate the immunogenicity and safety of 'IL-YANG Quadrivalent Seasonal Influenza Vaccine' in healthy Korean children and adolescents.
The study is an open-label(Part 1), Single-arm(Part 1), Randomized(Part 2), Double-blind(Part 2), Active comparator(Part 2) Phase III study. Before initiation of any protocol-specific activities, written informed consent is obtained from each patient and their legally acceptable representatives. Subjects who meet all of the eligibility criteria after screening assessments as specified in the protocol, are randomized into the test group or the comparator group in a ratio of 4 :1 and receive a single dose or two doses of the study vaccine. The investigator perform the efficacy (immunogenicity) and safety assessments throughout the study. Efficacy data are collected at Visit 1 (prior to vaccination) and at the end-of-study visit for efficacy (immunogenicity) assessments, and for safety assessment, subjects and their legally acceptable representatives are instructed to record any treatment-emergent adverse event in Patient Diary cards. For all randomized subjects, blood sample is obtained prior to vaccination, and the study vaccine 0.5mL is administered. For children aged from 3 years to \<9 years of age who have not previously received influenza vaccine, another dose of the study vaccine is administered 4 to 5 weeks after the first dose. Blood samples are collected 4 to 5 weeks after the last dose of the study drug for the assessment of antibody titer. All subjects are followed for 6 months after the last dose of the study drug for the safety assessments, and Month 6 follow-up visit is the end-of-study visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
379
A single 0.5mL dose administrated as an intramuscular injection.
A single 0.5mL dose administrated as an intramuscular injection.
The catholic university of Korea, Seoul ST. Marry's Hospital
Seoul, South Korea
Seroconversion 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) and Geometric Mean Ratio(GMR)
GMT and GMR of HI Antibody Titer Before Vaccination and After Vaccination
Time frame: Up to Day28(+7) after the last vaccination
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