A Multicenter, Double-blind, Parallel Phase III Study

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

Detailed Description
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A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III Study to Investigate the Efficacy(Immunogenicity) and Safety of GC3110A(Quadrivalent Influenza Vaccine) After Intramuscular Administration in Healthy Subjects

Official Title
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A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III Study to Investigate the Efficacy(Immunogenicity) and Safety of GC3110A(Quadrivalent Influenza Vaccine)

Conditions
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Influenza

Intervention / Treatment
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* Biological: GC3110A(Quadrivalent)
* Biological: GC Flu(Trivalent)
* Biological: GC3110A(Trivalent)


Participation Criteria
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Eligibility Criteria
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Criteria: Inclusion Criteria: Given written informed consent Healthy Korean adults (age: over 19 ) Korean adults who agree with 21 days follow up after vaccination and good compliance to study procedures Those who are able to comply with the requirements for the study Exclusion Criteria: Inability in written/verbal communication Subjects who have participated in other interventional study within 30 days Alcohol or drug abuse within 6 months Who got the treatment of psychotropic drugs and narcotic analgesic drugs within 6 months of enrollment Disorders in immune function History of Guillain-Barré syndrome Disease/medications which are likely to cause any severe bleeding Active infection or experience of fever (>38.0 ℃) within 72 hours following vaccination Oral temperature >38.0 ℃ at the vaccination day Erythema, tattoo, injury at shoulder (vaccination site) Hypersensitivity with egg, chicken, or any of the vaccine components, or Neomycin, Gentamicin Influenza vaccination within 6months Any vaccination within 30 days Concomitant medications/therapy such as immunosuppressants or immune modifying drugs, systemic corticosteroids, immunoglobulins, blood or blood- derived products, or anti-cancer chemotherapy or radiation therapy within3 months Pregnant or breast-feeding women Clinically significant underlying diseases or medical history at investigator's discretion

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: GC3110A(Quadrivalent)<br>0.5ml, intramuscular, a single dosing | Biological: GC3110A(Quadrivalent)<br>* GC3110A(Quadrivalent), 0.5ml, intramuscular, a single dosing at Day 1<br>* Other names: GC3110A;|
| Active Comparator: GC Flu (Trivalent)<br>0.5ml,intramuscular,a single dosing | Biological: GC Flu(Trivalent)<br>* GC Flu Pre-filled Syringe Inj.(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1<br>* Other names: GC Flu Pre-filled Syringe Inj.;|
| Active Comparator: GC3110A(Trivalent)<br>0.5ml,intramuscular,a single dosing | Biological: GC3110A(Trivalent)<br>* GC3110A(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1<br>* Other names: GC3110A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GMT rate of HI(Hemagglutination Inhibition) antibody for each strain | GMT (Active comparator) / GMT(Experimental) | Day 21 post vaccination | 
| Solicited adverse events following vaccination | Solicited injection site reactions: Pain, Tenderness, Erythema, Redness, Induration, and Swelling; Solicited systemic reactions: Fever, Sweating, Chill, Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia | Day0 up to 21 Day post vaccination | 
| Unsolicited adverse events following vaccination | It can be estimated by Toxicity Grading Scale for healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials | Day0 up to 21 Day post vaccination | 
| SCR rate of HI(Hemagglutination Inhibition) antibody for each strain | Difference of SCR (Experimental and Active comparator) | Day 21 post vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCR rate of HI(Hemagglutination Inhibition) antibody for each strain |  | Day0 up to 21 Day post vaccination | 
| SPR rate of HI(Hemagglutination Inhibition) antibody |  | Day 21 post vaccination | 
| GMT rate of HI(Hemagglutination Inhibition) antibody for each strain |  | Day 21 post vaccination | 
| Abnormalities in physical examination, Vital signs, clinical laboratory tests |  | Day 21 post vaccination | 
| SAE |  | Day 180 post vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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QIV, Quadrivalent Influenza Vaccine, Influenza vaccine, Vaccination