A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase III Study.
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase III Study to Investigate the Efficacy (Immunogenicity) and Safety of GC3106 (quadrivalent cell-culture based influenza vaccine) after Intramuscular Administration in Healthy Subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,630
GC3106(quadrivalent),0.5ml, intramuscular, a single dosing at Day 1
Fluarix™tetra Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1
Korea University Guro Hospital
Seoul, South Korea
The effect of the vaccination after 21 days of hemagglutination inhibition antibody (HI antibody) titer was measured through the GMT ratio
(GMT control drug/ GMT test drug)
Time frame: Day 21 post vaccination
The effect of the vaccination after 21 days of hemagglutination inhibition antibody (HI antibody) titer was measured through the difference between the SCRs
(SCR control drug- SPR test drug)
Time frame: Day 21 post vaccination
Solicited adverse events: Day 0~Day 6
Time frame: Day 0~Day 6
Unsolicited adverse events: Day 0~Day 21
Time frame: Day 0~Day 21
Rate of subjects achieving seroconversion, defined as post vaccination HI antibody titers
Time frame: 21 days after vaccination
Rate of subjects achieving seroprotection, defined as post vaccination HI antibody titers
Time frame: 21 days after vaccination
Vital sign and physical examination
Time frame: For 180 days after Visit 1
For 180 days after Visit 1, serious adverse events were presented with the results.
Time frame: For 180 days after Visit 1
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