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

NCT04381689 | Completed Phase 3

• 1 other identifier: IF4IC03
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 2

Brief Summary

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)

Conditions

Healthy

Keywords

Influenza; Influenza vaccine; Split influenza vaccine; Seasonal influenza vaccine

Outcome Measures

Primary Outcomes (2)

• Primary immunogenicity endpoints

  1. (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 ≥1:40 * A 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 2. (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)

• Seroprotection rate against Hemagglutination

  Seroprotection rate(a lower bound of 95 CI) ≥ 70%

  Up to Day28(+7) after the last vaccination

Secondary Outcomes (2)

• Geometric Mean Titer(GMT)

  Up to Day28(+7) after the last vaccination

• Geometric Mean Ratio(GMR)

  Up to Day28(+7) after the last vaccination

Study Arms (2)

IL-YANG FLU Vaccine Prefilled Syringe INJ.

EXPERIMENTAL

Teratect Prefilled Syringe Inj. 0.5mL

Biological: IL-YANG FLU Vaccine Prefilled Syringe INJ.

GSK FLU Vaccine Prefilled Syringe INJ.

ACTIVE COMPARATOR

Fluarix Tetra Pre-filled Syringe 0.5mL

Biological: Fluarix Tetra Pre-filled Syringe

Interventions

IL-YANG FLU Vaccine Prefilled Syringe INJ. BIOLOGICAL

Teratect Prefilled Syringe Inj. 0.5mL

IL-YANG FLU Vaccine Prefilled Syringe INJ.

Fluarix Tetra Pre-filled Syringe BIOLOGICAL

Fluarix Tetra Pre-filled Syringe 0.5mL

GSK FLU Vaccine Prefilled Syringe INJ.

Eligibility Criteria

• Age: 6 Months - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants 'from 6 months to under 3 years of age (≥6 months and \<3 years)
• Born after normal gestation period (which is more than 37 weeks)
• 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

You may not qualify if:

• A history of severe hypersensitivity reactions (e.g., anaphylaxis) to eggs, chicken, and other components of a vaccine including those derived from chicken
• A history of influenza vaccination within 6 months prior to screening
• Immuno dysfunction including immunodeficiency diseases or a family history thereof
• A history of Guillain-Barre syndrome
• Down's syndrome or cytogenetic disorders
• 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
• Risk of serious bleeding from an IM injection such as hemophilia patients or those on anticoagulants
• Acute fever with body temperature exceeding 38.0℃ within 72 hours prior to vaccination with the IP
• Vaccinated with other vaccines within 28 days prior to screening
• 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.
• Prior use of immunoglobulin or blood products within 3 months prior to screening or their anticipated use during the study
• Took antipyretics, analgesics, or non-steroidal anti-inflammatory drugs (NSAIDs) within 4 hours prior to vaccination with the IP
• Participated in another clinical study within 6 months prior to screening

Sponsors & Collaborators

• Il-Yang Pharm. Co., Ltd.: lead

Study Sites (2)

Korea University ANSAN Hospital

Ansan-si, Gyeonnggi-do, 15355, South Korea

Location

The Catholic University of Korea, Bucheon St. Mary's Hospital

Bucheon-si, Gyeonnggi-do, 15355, South Korea

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 11, 2020
• Study Start: October 23, 2024
• Primary Completion: May 20, 2025
• Study Completion: October 22, 2025
• Last Updated: July 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)