This study is aimed to confirm the lot-to-lot consistency of 3 consecutive batches of 'GC FLU® Pre-filled Syringe Injection' and 'GC FLU® Injection' in the lot-to-lot
This is a Post-Marketing, Multicentre, Open, Randomized Phase 4 Clinical Study. Subjects who gave voluntary written informed consent to participate in the study were screened for eligibility in the study, and those who met the eligibility criteria were randomized in the investigational group. An investigator assessed the effectiveness (immunogenicity) and safety of the study vaccine in each subject during his/her participation in the study. Subjects were randomized (Visit 1) into the investigational group according to a randomization table previously generated, and were vaccinated with influenza split vaccine, 'GC FLU®Pre-filled Syringe Injection' and 'GC FLU®Injection'. 12 Assessments for HI titre to each strain of influenza were performed at Visit 1 (pre-vaccination), and at Visit 3 (21 days after vaccination) for the efficacy (immunogenicity) evaluation \[Picture 1\].For the safety assessment, subject diaries were handed out to subjects, who were instructed to record any adverse event emerging ager the receipt of study vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,139
GMT (Geometric Mean Titre) of HI antibody titrebefore vaccination (Day 0) and after vaccination
Time frame: Day 21
The percentage of subjects achieving seroconversion for HI antibody (Seroconversion rate)
Time frame: Day21
GMT (Geometric Mean Titre) of HI antibody titre before vaccination (Day 0) and after vaccination
Time frame: Day 21
Solicited local adverse events (topical symptoms) and solicited general adverse events (systemic symptoms) occurring from the date of vaccination until 6 days after vaccination
Time frame: Day 6
The percentage of subjects achieving HI antibody titre ≥ 1:40 following the receipt of vaccination (Seroprotection rate).
Time frame: Day21
The percentage of subjects achieving seroconversion for HI antibody (Seroconversion rate)
Time frame: Day 21
The percentage of subjects achieving HI antibody titre ≥ 1:40 following the receipt of vaccination(Seroprotection rate).
Time frame: Day 21
Unsolicited adverse events occurring from the date of vaccination until 21 days after vaccination
Time frame: Day 21
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