Influenza, Human Clinical Trial
Official title:
Phase III Study to Evaluate Immunogenicity and Safety of 'Il-Yang Quadrivalent Seasonal Influenza Vaccine' in Healthy Korean Children and Adolescents
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.
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