Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactivated Split Influenza Vaccine in Healthy Korea Children
Condition: Healthy
MeSH terms: Influenza, Human
Intervention: IL-YANG FLU Vaccine Prefilled Syringe INJ.; VAXIGRIP Prefilled Syringe INJ.
Intervention description: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL; VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 416.0
Sex: All
Minimum age: 6 Months
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Influenza vaccine; Split influenza vaccine; Seasonal influenza vaccine

Summary:

      The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated
      Split Influenza Vaccine (IL-YANG FLU Vaccine Prefilled Syringe INJ.) administered as a single
      intramuscular injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy men or women aged from 6 months to < 18 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.