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

NCT04381689 | Active Not Recruiting Phase 3

• 1 other identifier: IF4IC03
• Study Type: interventional
• Target: 245
• 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)

• 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 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 PFS

EXPERIMENTAL

IL-YANG FLU Vaccine Prefilled Syringe INJ.

Biological: IL-YANG FLU Vaccine Prefilled Syringe INJ.

GSK PFS

ACTIVE COMPARATOR

Fluarix Tetra Pre-filled Syringe

Biological: Fluarix Tetra Pre-filled Syringe

Interventions

IL-YANG FLU Vaccine Prefilled Syringe INJ. BIOLOGICAL

Teratect Prefilled Syringe Inj. 0.5mL

IL-YANG PFS

Fluarix Tetra Pre-filled Syringe BIOLOGICAL

Fluarix Tetra Pre-filled Syringe 0.5mL

GSK PFS

Eligibility Criteria

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

You may qualify if:

• 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)).

You may not qualify if:

• 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.

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 (Estimated): May 31, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

KR (2)