Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactivated Split Influenza Vaccine in Healthy Korea Children

Overview

The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated Split Influenza Vaccine (IL-YANG FLU Vaccine Prefilled Syringe INJ.) administered as a single intramuscular injection.

This was a multi-center, randomized, double-blind, active-controlled study. Before initiation of any protocol-specific activities, written informed consent was obtained from each patient and their legally acceptable representatives (consent of the legally acceptable representative was required for children younger than 10 years of age, and for the some sites, for children younger than 7 years of age). Subjects who met all of the eligibility criteria after screening assessments as specified in the protocol, were randomized into the test group or the comparator group in a ratio of 5 to 1 according to the pre-generated site-specific randomization table, and received a single dose or two doses of the study vaccine. The investigator performed the efficacy (immunogenicity) and safety assessments throughout the study. Efficacy data were 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 were instructed to record any treatment-emergent adverse event in Patient Diary cards. For all randomized subjects, blood sample was obtained prior to vaccination, and the study vaccine 0.5mL or 0.25mL was administered to the deltoid muscle or anterolateral thigh muscle. For children aged from 6 months to \<9 years of age who had not been previously exposed to influenza virus or had not previously received influenza vaccine, another dose of the study vaccine was administered 4 to 5 weeks after the first dose. Blood samples were collected 4 to 5 weeks after the last dose of the study drug for the assessment of antibody titer. All subjects were followed for 6 months after the last dose of the study drug for the safety assessments, and Month 6 follow-up visit was the end-of-study visit.

Conditions

Interventions

Eligibility

Outcomes