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This study is a multi-center, randomized, double-blind Phase III clinical trial. The aim of the study is to describe the immunogenicity and safety of the trivalent cell culture-derived influenza vaccine compared to the trivalent egg-derived influenza vaccine among subjects.
Subjects are randomly assigned in a 4:1 ratio to NBP607-QIV versus Agrippal S1. 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 | Experimental | Trivalent Inactivated Cell Culture-derived Influenza Vaccine |
|
| Agrippal S1 | Active Comparator | Trivalent Inactivated Egg-derived Influenza Vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBP607 | Biological | For subjects 6 months to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 18 years of age, single intramuscular dose (0.25mL/0.5 mL) |
| Measure | Description | Time Frame |
|---|---|---|
| CHMP criteria | Seroprotection rate > 70%, Seroconversion rate > 40%, GMR > 2.5 | At Day 28 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity in subjects with a pre-vaccination HI antibody titer < 1:80 | At Day 28 post-vaccination | |
| Immunogenicity compared to control group | 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 |
| Ui Yoon Choi | Catholic University of Korea Saint Paul's Hospital | Principal Investigator |
| Chi Eun Oh | Kosin University Gospel Hospital | Principal Investigator |
| Byung Wook Eun | Eulji General Hospital | Principal Investigator |
| Taek Jin Lee | CHA University | Principal Investigator |
| Ki Hwan Kim | Severance Children's Hospital | Principal Investigator |
| Dong Ho Kim | Korea Institute of Radiological and Medical Science | Principal Investigator |
| Nam Hee Kim | Inje University Ilsan Paik Hospital | Principal Investigator |
| Dae Sun Jo | Chonbuk National University Hospital | Principal Investigator |
| Seon Hee Shin |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Agrippal S1 | Biological | For subjects 6 months to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 18 years of age, single intramuscular dose (0.25mL/0.5 mL) |
|
| Incidence rate of Advers Event (AE) |
Including Solicited Local AE, Solicited Systemic AE, and Unsolicited AE |
| During 7 days post-vaccination for Solicited AE and during 28 days post-vaccination for Unsolicited AE |
| Incidence rate of Severe Adverse Event (SAE) | During 6 months post-vaccination |
| Vital Sign | At Day 0 and at Day 28 post-vaccination |
| Physical Examination | At Day 0 and at Day 28 post-vaccination |
| Hallym University Dongtan Sacred Heart Hospital |
| Principal Investigator |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |