A Multicenter, Double-blind, Parallel, Non-inferiority, Phase III Study

Study Overview
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Brief Summary
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A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase III Study.

Detailed Description
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A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase III Study to Investigate the Efficacy (Immunogenicity) and Safety of GC3106 (quadrivalent cell-culture based influenza vaccine) after Intramuscular Administration in Healthy Subjects.

Official Title
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A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase III Study to Investigate the Efficacy (Immunogenicity) and Safety of GC3106 (Quadrivalent Cell-culture Based Influenza Vaccine)

Conditions
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Influenza

Intervention / Treatment
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* Biological: GC3106(quadrivalent cell-culture based influenza vaccine)
* Biological: Fluarix™tetra Syringe Inj.(quadrivalent influenza vaccine)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Given written informed consent Healthy Korean adults (age: between over 19) Women of childbearing age with negative Urine hCG in screening visit Exclusion Criteria: Subjects unable to communicate (illiterate or who cannot understand the questionnaire and/or the study subject diary) Subjects participating in another clinical study or has participated in a clinical study in the last 30 days (the participation should be based on the final dose of the investigational drug) Subjects with impaired immune functions that include immune deficiency diseases Subjects with a history of Guillain-Barre syndrome Hemophilia patients at risk of serious bleeding with intramuscular injection or who had taken an anticoagulant Subjects with symptoms of active infection or who had higher than 38.0℃ fever before the investigational product administration Subjects to be planned to have a surgery in the study duration or subject who the investigator decides exception because of a clinical significant chronic or malignant disease or medical history to interrupt the study procedure Subjects with erythema and/or a tattoo in the injection site of the scheduled investigational product (the deltoid muscle) that is hard to identify the topical toxicity Subjects with a history of allergic reaction to eggs or chicken, the vaccine components, and/or Formaldehyed, Gentamicin and Sodium Deoxychloate Subjects who had been administered the influenza vaccine 6 months before the scheduled vaccination of the investigational product Subjects who had been vaccinated with another vaccine within 30 days before the investigational product administration or had a scheduled vaccination during the clinical study period Subjects who had received an immunosuppressant, immunity-modifying drug, cytotoxic chemotherapy that can affect his or her immune system, or radiation therapy within 3 months before the investigational product administration Subjects receiving systemic steroids (more than 20 mg/day of prednisolone administered everyday over 14 days or more than 700 mg of a cumulative dose during the same period of time) within 3 months before the administration (Day 1) of the investigational product (topical ointments, eye drops, inhalants or intranasally/intramuscularly administered drugs, or topically applied drugs such as ligaments; unless administered every other day over 14 days) Subjects who had received immunoglobulin or a blood-derived product within 3 months before being vaccinated with the investigational product or is scheduled to receive those products during the clinical study period Pregnant women, nursing mothers, or women of childbearing age who do not perform adequate contraception (using a condom, diaphragm, IUD, or hormonal contraception 21 days before vaccination with the investigational product or whose male partner had undergone a vasectomy) Subjects who have other clinically significant medical or psychiatric examination findings deemed by the investigator to make them ineligible for participation in this clinical study

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GC3106(quadrivalent)<br>0.5ml, intramuscular, a single dosing | Biological: GC3106(quadrivalent cell-culture based influenza vaccine)<br>* GC3106(quadrivalent),0.5ml, intramuscular, a single dosing at Day 1<br>* Other names: GC3106;|
| Active Comparator: Fluarix™tetra Syringe Inj.(Quadrivalent)<br>0.5ml,intramuscular,a single dosing | Biological: Fluarix™tetra Syringe Inj.(quadrivalent influenza vaccine)<br>* Fluarix™tetra Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1<br>* Other names: Fluarix™tetra Syringe Inj.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of the vaccination after 21 days of hemagglutination inhibition antibody (HI antibody) titer was measured through the GMT ratio | (GMT control drug/ GMT test drug) | Day 21 post vaccination | 
| The effect of the vaccination after 21 days of hemagglutination inhibition antibody (HI antibody) titer was measured through the difference between the SCRs | (SCR control drug- SPR test drug) | Day 21 post vaccination | 
| Solicited adverse events: Day 0 Day 6 |  | Day 0 Day 6 | 
| Unsolicited adverse events: Day 0 Day 21 |  | Day 0 Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of subjects achieving seroconversion, defined as post vaccination HI antibody titers |  | 21 days after vaccination | 
| Rate of subjects achieving seroprotection, defined as post vaccination HI antibody titers |  | 21 days after vaccination | 
| Vital sign and physical examination |  | For 180 days after Visit 1 | 
| For 180 days after Visit 1, serious adverse events were presented with the results. |  | For 180 days after Visit 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CCIV, quadrivalent cell-culture based influenza vaccine, Influenza vaccine, Vaccination