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

Il-Yang Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Healthy

Treatments: Biological: Fluarix Tetra Pre-filled Syringe; Biological: IL-YANG FLU Vaccine Prefilled Syringe INJ.

Study type: Interventional

Funder types: Industry

Identifiers

NCT04381689

IF4IC03

Details and patient eligibility

About

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)

Full description

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

Enrollment: 245 estimated patients

Sex: All

Ages: 6 months to 3 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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245 participants in 2 patient groups

IL-YANG PFS

Experimental group

Description:

IL-YANG FLU Vaccine Prefilled Syringe INJ.

Treatment:

Biological: IL-YANG FLU Vaccine Prefilled Syringe INJ.

GSK PFS

Active Comparator group

Description:

Fluarix Tetra Pre-filled Syringe

Treatment:

Biological: Fluarix Tetra Pre-filled Syringe