Safety, Tolerability, and Immunogenicity of GC3106 (Quadrivalent Cell-culture Based Influenza Vaccine)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of GC3106 after single intramuscular administration in Korean healthy adults.

Detailed Description
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This study is the first in human trial of GC3106 and is designed as an adaptive Phase I/IIa to ensure participants protection. Part A is an open-label and single arm study in 9 healthy volunteers. Data and Safety Monitoring Board (DSMB) will review the solicited/unsolicited adverse events conditionally if any toxicity of Grade 3 or 4 has been reported during 7 days after vaccination from the first 9 healthy volunteers. Part B is a randomized (2:1), double-blind, active controlled study and a total of 75 volunteers will participate in this part. Adverse events assessment will be done according to the 'Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials'.

Official Title
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A Randomized (Part B), Open-label (Part A) or Double-blind (Part B), Active-controlled (Part B) Phase I/IIa Study to Investigate the Safety, Tolerability, and Immunogenicity of GC3106 (Quadrivalent Cell-culture Based Influenza Vaccine)

Conditions
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Influenza

Intervention / Treatment
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* Biological: Quadrivalent cell-culture based influenza vaccin
* Biological: Trivalent 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 and under 65) 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 Heavy drinkers or subjects who do not agree to stop drinking for 3 days before vaccination and other 3 days after vaccination Who got the treatment of psychotropic drugs and narcotic analgesic drugs within 6 months of enrollment Hypersensitivity with drug or active ingredient 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) 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
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quadrivalent cell-culture based influenza vaccin<br>Day 1: GC3106, 0.5ml, intramuscular, a single dosing | Biological: Quadrivalent cell-culture based influenza vaccin<br>* GC3106, 0.5ml, intramuscular, a single dosing at Day 1<br>* Other names: GC3106;|
| Active Comparator: Trivalent influenza vaccine<br>Day 1: GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing | Biological: Trivalent influenza vaccine<br>* GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1<br>* Other names: GC Flu Pre-filled Syringe Inj.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 up to 7 Days 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 | Day 1 up to 22 Days post vaccination | 
| Abnormalities in physical examination, vital signs, and/or clinical laboratory tests |  | Day 22 post vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprotection rate of HI (Hemagglutination Inhibition) antibody for each strain |  | Day 22 post vaccination | 
| Seroconversion rate of HI (Hemagglutination Inhibition) antibody for each strain |  | Day 22 post vaccination | 
| GMT(geometric mean titers) for each strain |  | Day 22 post vaccination | 

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