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

Study Overview
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Brief Summary
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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)

Detailed Description
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The study is an Randomized, Double-blind, Active controlled Phase III study.

Official Title
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Phase Ⅲ, Randomized, Double-blind, Active Controlled to Evaluate the Immunogenicity and Safety of IL-YANG Quadrivalent Seasonal Influenza Vaccine in Healthy Infants From 6 Months to Under 3 Years of Age(≥ 6 Months and < 3 Years)

Conditions
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Healthy

Intervention / Treatment
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* Biological: IL-YANG FLU Vaccine Prefilled Syringe INJ.
* Biological: Fluarix Tetra Pre-filled Syringe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy men or women aged from 6 months to < 3 years Subjects were born after full term pregnancy (37 weeks) 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 10 years of age (and for subjects younger than 7 years of age for the some institutions)). Exclusion Criteria: Subject with a known allergy to eggs, chicken, neomycin, gentamicin or any components of the study vaccine 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 30 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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IL-YANG PFS<br>IL-YANG FLU Vaccine Prefilled Syringe INJ. | Biological: IL-YANG FLU Vaccine Prefilled Syringe INJ.<br>* Teratect Prefilled Syringe Inj. 0.5mL<br>|
| Active Comparator: GSK PFS<br>Fluarix Tetra Pre-filled Syringe | Biological: Fluarix Tetra Pre-filled Syringe<br>* Fluarix Tetra Pre-filled Syringe 0.5mL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rate against Hemagglutination Inhibition(HI) antibody | Seroconversion rate(a lower bound of 95 CI) ≥ 40% | Up to Day28(+7) after the last vaccination | 
| Seroprotection rate against Hemagglutination | Seroprotection rate(a lower bound of 95 CI) ≥ 70% | Up to Day28(+7) after the last vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titer(GMT) | GMT of HI Antibody Titer Before Vaccination and After Vaccination | Up to Day28(+7) after the last vaccination | 
| Geometric Mean Ratio(GMR) | GMR of HI Antibody Titer Before Vaccination and After Vaccination | Up to Day28(+7) after the last vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Influenza vaccine, Split influenza vaccine, Seasonal influenza vaccine