Study to Evaluate the Immunogenicity and Safety of 'IL-YANG Quadrivalent Influenza Vaccine Inj.'
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: IL-YANG Quadrivalent Influenza Vaccine; IL-YANG Flu Vaccine Prefilled Syringe; IL-YANG Trivalent Influenza Vaccine
Intervention description: A single 0.5mL dose administrated as an intramuscular injection.; A single 0.5mL dose administrated as an intramuscular injection.; A single 0.5mL dose administrated as an intramuscular injection.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1794.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study evaluates the immunogenicity and safety of 'IL-YANG Quadrivalent Influenza Vaccine
      Inj.' in healthy male and female adults at the age of 19 or older.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy men and women at the age of 19 or older.

          -  Women of childbearing potential must have a negative pregnancy test (urine HCG) at the
             screening visit.

          -  Subjects who were given, and fully understood, the information about the study, and
             have provided voluntary written informed consent to participate in the study and to
             comply with all applicable study requirements.

        Exclusion Criteria:

          -  Subjects with known allergy to eggs, chicken, or any components of the study vaccine.

          -  Subjects who had received an influenza vaccine within the last 6 months prior to study
             entry.

          -  Subjects who have immune function disorders including immunodeficiency diseases or
             relevant family history.

          -  Subjects who donated blood within 1 week prior to vaccination or plan to donate blood
             during the period from Day 1 to Month 7 of vaccination.

          -  Subjects with a history of Guillain-Barre syndrome.

          -  Subjects with Down's syndrome or cytogenetic disorders.

          -  Subjects who are considered by the investigator to have difficulties in study
             participation due to severe chronic diseases (e.g., cardiovascular diseases except
             controlled hypertension and respiratory diseases with respiratory failure, metabolic
             diseases, renal function disorders, hemoglobinopathy, etc.).

          -  Subjects with hemophilia or coagulation disorder, who are at increased risk of serious
             bleeding during intramuscular injection.

          -  Subjects who had an acute fever with body temperature > 38.0 ºC within 72 hours prior
             to administration of the study vaccine.

          -  Subjects who had received another vaccine within 28 days before administration of the
             study vaccine or are planning to receive another vaccine during the study.

          -  Subjects who had received immunosuppressants or immune modifying drugs within 3 months
             prior to the investigational product vaccination.

               1. Azathioprine, cyclosporin, interferon, G-CSF, tacrolimus, everolimus, sirolimus,
                  etc.

               2. High dose corticosteroids (a subject taking high doses, which is defined as
                  2mg/kg/day or higher of prednisolone administered for longer than 14 consecutive
                  days, is not eligible for this study. The use of inhaled, nasal and topical
                  corticosteroids is allowed, regardless of doses).

          -  Subjects who had previously received immunoglobulin or blood-derived products within
             the last 3 months prior to administration of the study vaccine, or are scheduled to
             receive a treatment with blood-derived products during the study.

          -  Subjects who had participated in another clinical trial within the 30 days before
             administration of the study vaccine.

          -  Female subjects of childbearing potential who do not agree to use an acceptable method
             of birth control* for this study during the study period.

               -  Medically acceptable methods of birth control: condom, injectable or implantable
                  contraceptives, intrauterine device, or oral contraceptives, etc.

          -  Subjects with other clinically significant medical or psychiatric illness who in the
             investigator's opinion, are not be suitable for the study.