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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBP607-QIV 0.5mL | Experimental | Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine |
|
| NBP607-TIV 0.25mL | Active Comparator | Trivalent Inactivated Cell Culture-derived Influenza Vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBP607-QIV | Biological | 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] |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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] | At Day 28 post-vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yun Kyung Kim | Korea University Ansan Hospital | Study Chair |
| Hye Kyung Cho | Gachon University Gil Medical Center | Principal Investigator |
| Ki Hwan Kim | Incheon St.Mary's Hospital | Principal Investigator |
| Byung Wook Eun | Eulji General Hospital | Principal Investigator |
| Yae Jean Kim | Samsung Medical Center | Principal Investigator |
| Jina Lee | Asan Medical Center | Principal Investigator |
| Dong Ho Kim | Korea Institute of Radiological and Medical Science | Principal Investigator |
| Hwang Min Kim | Wonju Severance Christian Hospital | Principal Investigator |
| Nam Hee Kim | Inje University Ilsan Paik Hospital | Principal Investigator |
| Dae Sun Jo |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University ANSAN hospital | Ansan | South Korea | ||||
| Chungnam National University Hospital |
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| NBP607-TIV | Biological | 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] |
|
| Chonbuk National University Hospital |
| Principal Investigator |
| Eun Young Cho | Chungnam National University Hospital | Principal Investigator |
| Seon Hee Shin | Hallym University Dongtan Sacred Heart Hospital | Principal Investigator |
| Daejeon |
| South Korea |
| Inje University Ilsan Paik Hospital | Goyang | South Korea |
| 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 |
| Samsung Medical Center | Seoul | South Korea |
| Wonju Severance Christian Hospital | Wŏnju | South Korea |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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