This study is a multi-center, randomized, double-blind Phase III Clinical trial. The purpose of this study is to assess the immunogenicity and safety of the quadrivalent cell culture-derived influenza vaccine compare to the trivalent cell culture-derived influenza vaccine in children aged 6\~35 months.
Subjects are randomly assigned in a 2:1 ratio to NBP607-QIV 0.5mL versus NBP607-TIV 0.25mL. To assess the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained at pre-vaccination and 28 days post-vaccination. To assess the safety, solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination are assessed and reported. The serious adverse events are collected during 6 months post-vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
171
For subjects 6 months to 35 months of age, Single dose administration, Intra-muscular \[\* 2 doses for subjects without influenza vaccination history, administered at least 4 weeks apart\]
For subjects 6 months to 35 months of age, Single dose administration, Intra-muscular \[\* 2 doses for subjects without influenza vaccination history, administered at least 4 weeks apart\]
Korea University ANSAN hospital
Ansan, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Inje University Ilsan Paik Hospital
Goyang, South Korea
HI[hemagglutination Inhibition] derived parameters: Seroprotection rate(a lower bound of 95% CI) > 70%
Seroprotection rate is the proportion of subjects achieving a post-vaccination HI titer ≥ 1:40
Time frame: At Day 28 post-vaccination
HI[hemagglutination Inhibition] derived parameters: Seroconversion rate(a lower bound of 95% CI) > 40%
Seroconversion is defined as a pre-vaccination HI titer of \<1:10 with a post-vaccination titer ≥ 1:40, and a significant increase was defined as at least a four fold increase in HI titer
Time frame: At Day 28 post-vaccination
HI[hemagglutination Inhibition] derived parameters: GMR (a lower bound of 95% CI) > 2.5
GMR \[geometric mean ratio, mean fold increase\]
Time frame: At Day 28 post-vaccination
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Gachon University Gil Medical center
Incheon, South Korea
The Catholic University of Korea, Incheon ST. Mary's Hospital
Incheon, South Korea
Chonbuk National University Hospital
Jeonju, South Korea
Asan Medical Center
Seoul, South Korea
Eulji General Hospital
Seoul, South Korea
Hallym University Dongtan Sacred Heart Hospital
Seoul, South Korea
Korea Institute of Radiological and Medical Science
Seoul, South Korea
...and 2 more locations