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

Phase Ⅲ, Multi-national, 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: Completed
• 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 (Actual): 260
• Phase: Phase 3

Contacts and Locations

Study Locations

• South Korea
  • Gyeonnggi-do
    • Ansan-si, Gyeonnggi-do, South Korea, 15355
      • Korea University Ansan Hospital
    • Bucheon-si, Gyeonnggi-do, South Korea, 15355
      • The Catholic University of Korea, Bucheon St. Mary's Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Healthy infants 'from 6 months to under 3 years of age (≥6 months and <3 years)
2. Born after normal gestation period (which is more than 37 weeks)
3. A subject's legally acceptable representative has voluntarily decided on participation and provided written informed consent after receiving and understanding a detailed explanation on this study

Exclusion Criteria:

1. A history of severe hypersensitivity reactions (e.g., anaphylaxis) to eggs, chicken, and other components of a vaccine including those derived from chicken
2. A history of influenza vaccination within 6 months prior to screening
3. Immuno dysfunction including immunodeficiency diseases or a family history thereof
4. A history of Guillain-Barre syndrome
5. Down's syndrome or cytogenetic disorders
6. Severe chronic diseases (e.g., cardiovascular diseases excluding controlled hypertension, respiratory diseases with respiratory failure, metabolic diseases, renal dysfunction, hemoglobinopathy, etc.) that, in the opinion of investigator, preclude a subject's participation in the study
7. Risk of serious bleeding from an IM injection such as hemophilia patients or those on anticoagulants
8. Acute fever with body temperature exceeding 38.0℃ within 72 hours prior to vaccination with the IP
9. Vaccinated with other vaccines within 28 days prior to screening

10. Received immunosuppressants or immune-modifying drugs within 3 months prior to screening

    ① Azathioprine, cyclosporin, interferon, granulocyte colony-stimulating factor (G-CSF), tacrolimus, everolimus, sirolimus, etc.

    ② Use of high-dose corticosteroids (e.g., continued use of prednisolone at a dose of ≥2 mg/kg/day in subjects weighing <10 kg for 14 days or longer or at a dose of ≥20 mg/day in subjects weighing ≥10 kg for 14 days or longer). However, inhaled, intranasal, or topical corticosteroids are permitted regardless of their dose.

11. Prior use of immunoglobulin or blood products within 3 months prior to screening or their anticipated use during the study
12. Took antipyretics, analgesics, or non-steroidal anti-inflammatory drugs (NSAIDs) within 4 hours prior to vaccination with the IP
13. Participated in another clinical study within 6 months prior to screening
14. Determined ineligible based on other clinically significant medical or psychiatric findings by the investigator

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 FLU Vaccine Prefilled Syringe INJ.; Teratect Prefilled Syringe Inj. 0.5mL	Biological: IL-YANG FLU Vaccine Prefilled Syringe INJ.; Teratect Prefilled Syringe Inj. 0.5mL
Active Comparator: GSK FLU Vaccine Prefilled Syringe INJ.; Fluarix Tetra Pre-filled Syringe 0.5mL	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
Seroprotection rate against Hemagglutination	Seroprotection rate(a lower bound of 95 CI) ≥ 70%	Up to Day28(+7) after the last vaccination
Primary immunogenicity endpoints	(Seroconversion rate† is) Proportion of subjects achieving seroconversion* for HI antibody after vaccination with the IP†† Seroconversion rate (SCR)* Seroconversion:A pre-vaccination (prior to vaccination with the IP, Day 0) HI antibody titer <1:10 and a post-vaccination (at Day 28 after the last vaccination with the IP) HI antibody titer ≥1:40A pre-vaccination (prior to vaccination with the IP, Day 0) HI antibody titer ≥1:10 and at least a 4-fold increase in post-vaccination (at Day 28 after the last vaccination with the IP) HI antibody titer; (Seroprotection rate‡ is) Proportion of subjects achieving seroprotection** for HI antibody after vaccination with the IP‡ ‡ Seroprotection rate (SPR) ** Seroprotection: HI antibody titer ≥1:40 at Day 28 after the last vaccination with the IP	From a pre-vaccination (prior to vaccination with the IP, Visit1) to a post-vaccination (at Day 28 after the last vaccination with the IP)

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 (Actual): October 23, 2024
• Primary Completion (Actual): May 20, 2025
• Study Completion (Actual): October 22, 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 (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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