A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,299
GC3110A(Quadrivalent), 0.5ml, intramuscular, a single dosing at Day 1
GC Flu Pre-filled Syringe Inj.(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1
GC3110A(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1
Korea University Guro Hospital
Seoul, South Korea
GMT rate of HI(Hemagglutination Inhibition) antibody for each strain
GMT (Active comparator) / GMT(Experimental)
Time frame: 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
Time frame: 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
Time frame: Day0 up to 21 Day post vaccination
SCR rate of HI(Hemagglutination Inhibition) antibody for each strain
Difference of SCR (Experimental and Active comparator)
Time frame: Day 21 post vaccination
SCR rate of HI(Hemagglutination Inhibition) antibody for each strain
Time frame: Day0 up to 21 Day post vaccination
SPR rate of HI(Hemagglutination Inhibition) antibody
Time frame: Day 21 post vaccination
GMT rate of HI(Hemagglutination Inhibition) antibody for each strain
Time frame: Day 21 post vaccination
Abnormalities in physical examination, Vital signs, clinical laboratory tests
Time frame: Day 21 post vaccination
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SAE
Time frame: Day 180 post vaccination