This study aims to demonstrate the immunogenic efficacy of GC FLU Quadrivalent Pre-filled Syringe inj. (GC FLU), a quadrivalent influenza virus vaccine, is non-inferior to the active control, Fluarix Tetra. This study is designed to be a randomized, open-labelled, active-controlled, parallel, phase III study recruiting subjects from multiple study sites. Approximately 840 eligible subjects are planned to enroll in order to obtain 800 evaluable (= per-protocol) subjects. Subjects will be randomized and assigned to GC FLU or Fluarix Tetra (active control, AC) group in 1:1 ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
842
A single dose administration of GC FLU Quadrivalent will be through intramuscular injection.
A single dose administration of Fluarix Tetra will be through intramuscular injection.
National Taiwan University Hospital
Taipei, Taiwan
Taipei Municipal Wan Fang Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan
The Geometric Mean Titer (GMT) Ratio
The non-inferior immunogenicity of GC FLU compared to active control in terms of HAI titers against each virus strain at 21 days after the vaccination.
Time frame: 21 days after the vaccination
The Seroconversion Rate
The non-inferior immunogenicity of GC FLU compared to active control in terms of HAI titers against each virus strain at 21 days after the vaccination.
Time frame: 21 days after the vaccination
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