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'.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
84
GC3106, 0.5ml, intramuscular, a single dosing at Day 1
GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1
Korea University Guro Hospital
Seoul, South Korea
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.
Time frame: 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
Time frame: Day 1 up to 22 Days post vaccination
Abnormalities in physical examination, vital signs, and/or clinical laboratory tests
Time frame: Day 22 post vaccination
Seroprotection rate of HI (Hemagglutination Inhibition) antibody for each strain
Time frame: Day 22 post vaccination
Seroconversion rate of HI (Hemagglutination Inhibition) antibody for each strain
Time frame: Day 22 post vaccination
GMT(geometric mean titers) for each strain
Time frame: Day 22 post vaccination
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