A Study to Evaluate the Efficacy and Safety of 'GC3110A(QIV)' in Healthy Children
Condition: Influenza
Study type: Interventional
Phase: Phase 3

Summary: 
      1. Part 1 If study subject and legal guardians who decide voluntarily to participate the
           clinical trial, and sign the Informed Consent Form (In the case of study subject less
           than 7 years of age, written informed consent by study subject's legal guardians), study
           subjects eligible for participating this trial protocol were assigned to test group and
           receiving the test drug 1 times or 2 times according to age.

        2. Part 2 If study subject and legal guardians who decide voluntarily to participate the
           clinical trial, and sign the Informed Consent Form(In the case of study subject less
           than 7 years of age, written informed consent by study subject's legal guardians), the
           study subjects eligible for participating this trial protocol were assigned to test
           group or control group with the ratio of 4:1 and receiving the test drug 1 times or 2
           times according to age as below;

             -  6 m ~ 3 years

             -  3 years ~ 9 years

             -  9 years ~ 19 years
    

Detailed description: 
      1. Part 1 If study subject and legal guardians who decide voluntarily to participate the
           clinical trial, and sign the Informed Consent Form (In the case of study subject less
           than 7 years of age, written informed consent by study subject's legal guardians), study
           subjects eligible for participating this trial protocol were assigned to test group and
           receiving the test drug 1 times or 2 times according to age.

           The safety data collected during part A will be reviewed by DSMB to evaluate the
           solicited adverse events for 7 days after each vaccination.

           However, if no toxicity higher than grade 3 according to FDA guidance the study was
           allowed to proceed to Part 2 without DSMB review.

           Efficacy and safety assessment methods, and visiting schedule will be the same as Part
           2.

        2. Part 2 If study subject and legal guardians who decide voluntarily to participate the
           clinical trial, and sign the Informed Consent Form(In the case of study subject less
           than 7 years of age, written informed consent by study subject's legal guardians), the
           study subjects eligible for participating this trial protocol were assigned to test
           group or control group with the ratio of 4:1 and receiving the test drug 1 times or 2
           times according to age as below;

             -  6 m ~ 3 years

             -  3 years ~ 9 years

             -  9 years ~ 19 years The investigator will evaluate the efficacy and safety of the
                test product while clinical trial.

      Blood samples will be collected at visit 1 for efficacy evaluation. The study subject and
      their legal guardians will be educated to daily record AEs after vaccination on the patient
      diary to evaluate the safety.

      At visit1, blood samples will be collected from randomized study subjects and investigational
      drug of doses of 0.25mL or 0.5mL according to age will be intramuscularly injected. However,
      those who had not been vaccinated with influenza vaccine, aged of over than 6 months to less
      than 9 years study subjects, will re-visit and have the 2nd vaccination, 4~5 weeks after the
      1st vaccination.

      After 4~5 weeks since last vaccination, study subjects will visit and blood sample will be
      collected. And the serious adverse events occurred during 180 days after the final
      vaccination will be checked through the telephone visit.

      The study subjects with 1 dose of vaccine will have 4 visits including Visit 1~2 and Visit
      5~6. The study subjects with 2 dose of vaccine will have 6 visits including Visit 1~2, Visit
      3~4 and Visit 5~6.
    

Intervention name(s): GC3110A; GCFLU Pre-filled Syringe inj.
Intervention type(s): Biological; Biological
Intervention description(s): A single 0.5mL dose intramuscular injection; A single 0.5mL dose intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention