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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.
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'.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quadrivalent cell-culture based influenza vaccin | Experimental | Day 1: GC3106, 0.5ml, intramuscular, a single dosing |
|
| Trivalent influenza vaccine | Active Comparator | Day 1: GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrivalent cell-culture based influenza vaccin | Biological | GC3106, 0.5ml, intramuscular, a single dosing at Day 1 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Woo Joo KIM, M.D., Ph.D | Korea University Guro Hospital | Principal Investigator |
| Chang-Hee LEE, M.D. | Green Cross Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| Trivalent influenza vaccine | Biological | GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1 |
|
|
| GMT(geometric mean titers) for each strain | Day 22 post vaccination |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |