Immunogenicity and Safety for 'IL-YANG Quadrivalent Influenza Vaccine' in Healthy Korean Children and Adolescents

Il-Yang Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Influenza, Human

Treatments

Biological: IL-YANG Flu Vaccine Pre-filled Syringe

Biological: IL-YANG Quadrivalent Influenza Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT03445468

IF4CH03

Details and patient eligibility

About

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.

Full description

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.

Enrollment

379 patients

Sex

All

Ages

3 to 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy men or women aged from 3 years to < 19 years
Subjects were born after full term pregnancy (37 weeks)
Woman of childbearing potential must have a negative result from Urine Human Chorionic Gonadotropin(HCG) test at the screening visit.
Voluntary written informed consent was obtained from the subject and the subject's legally acceptable representative (consent of legally acceptable representative was required for subjects younger than 7 years of age)

Exclusion criteria

Subject with a known serious allergy reaction after influenza vaccination or to any component vaccine including eggs
Subject who had received an influenza vaccine within the last 6 months
Subject who has, or has a family history of, an immune system disorder including immune deficiency disease
Subject with a history of Guillain-Barre syndrome
Subject with Down's syndrome or cytogenetic disorders.
Subject with severe chronic disease which in the investigator's opinion would not make the subject a good candidate for the clinical trial
Subject with hemophilia or being treated with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection
Subject who had an acute fever with body temperature > 38.0 Cº within 72 hours prior to administration of the study vaccine
Subject who had previously received another vaccine within 28 days before administration of the study drug, or is scheduled to receive another vaccine during the study period.
Subject who had received immunosuppressant or immune modifying drug within the last 3 months prior to administration of the study vaccine
Subject who had previously received immunoglobulin or blood-derived products within the last 3 months prior to administration of the study vaccine, or is expecting to be treated with immunoglobulin or blood-derived products during the study.
Subject who had participated in another experimental study within 28 days prior to administration of the study vaccine
Subject with other clinically significant medical or psychological condition who in the investigator's opinion would not be suitable for the study.