The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated Split Influenza Vaccine (IL-YANG FLU Vaccine Vial INJ.) administered as a single intramuscular injection
This was an open-label study. Subjects providing voluntary written informed consent underwent protocol-specific assessments and tests within 4 weeks prior to administration of the study vaccine, and those who met all of the inclusion/exclusion criteria and were considered eligible were sequentially enrolled in the study. Subjects enrolled in the study received 0.5ml of the study vaccine as an intramuscular injection in the deltoid muscle, and returned to the clinic every day for the first 3 days. On Day 14 post-vaccination, subjects underwent the safety assessments. On Day 28 post-vaccination, subjects returned for safety and immunogenicity assessments.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
44
0.5mL
Seoul St. Mary's Hospital,The Catholic University of Korea
Seoul, South Korea
Solicited local & general AE, Unsolicited AE
Solicited local reaction: pain, tenderness, redness, swelling Solicited general reactions: fever, nausea/vomiting, diarrhea, headache, fatigue, myalgia
Time frame: up to Day28(+7)
Percentage of subjects achieving seroprotection for HI antibody after administration of the study vaccine
Seroprotection: HI antibody titer ≥ 1:40 28 days after the administration of the study vaccine
Time frame: Day28(+7)
GMT of HI antibody titer before vaccination and after vaccination
GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio), as measured by pre-vaccination (Day 0) HI antibody titer and post-vaccination (vaccination + 28 days) HI antibody titer
Time frame: Day28(+7)
Percentage of subjects with a pre-vaccination (Day 0) HI antibody titer < 1:40, and a minimum four-fold rise in post-vaccination (vaccination + 28 days) HI antibody titer
Time frame: Day28(+7)
Vital signs measurements, physical examination findings, ECG results, and laboratory measurements (hematology, biochemistry and urinalysis)
Time frame: Day28(+7)
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