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

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)

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Biological: IL-YANG FLU Vaccine Prefilled Syringe INJ.; Biological: Fluarix Tetra Pre-filled Syringe

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 245
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 3 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Il-Yang Pharm. Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 8, 2020
• First Posted (Actual): May 11, 2020

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Influenza; Influenza vaccine; Split influenza vaccine; Seasonal influenza vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: IF4IC03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No