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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-23

Study Completion Date

2025-06-30

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)

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Detailed Description

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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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IL-YANG PFS

IL-YANG FLU Vaccine Prefilled Syringe INJ.

Group Type EXPERIMENTAL

IL-YANG FLU Vaccine Prefilled Syringe INJ.

Intervention Type BIOLOGICAL

Teratect Prefilled Syringe Inj. 0.5mL

GSK PFS

Fluarix Tetra Pre-filled Syringe

Group Type ACTIVE_COMPARATOR

Fluarix Tetra Pre-filled Syringe

Intervention Type BIOLOGICAL

Fluarix Tetra Pre-filled Syringe 0.5mL

Interventions

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IL-YANG FLU Vaccine Prefilled Syringe INJ.

Teratect Prefilled Syringe Inj. 0.5mL

Intervention Type BIOLOGICAL

Fluarix Tetra Pre-filled Syringe

Fluarix Tetra Pre-filled Syringe 0.5mL

Intervention Type BIOLOGICAL

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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes