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The purpose of this study is to describe the immunogenicity and safety of the cell culture-derived influenza vaccine compared with the egg-derived influenza vaccine among subjects.
To describe the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained pre-vaccination and 21 days post-vaccination.
To describe the safety, the time of onset and duration of local and systemic solicited adverse events are assessed and reported. Unsolicited adverse events and serious adverse events are collected and categorized throughout the study period.
This is a multi-center, randomized, double-blind study in healthy adult and elderly subjects. Subjects receive a single dose of one of the influenza vaccine formulations and provide blood samples for immunogenicity assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBP607 | Experimental | cell culture-derived trivalent inactivated subunit influenza vaccine |
|
| Agrippal S1 | Active Comparator | egg-derived trivalent inactivated subunit influenza vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBP607 | Biological | 0.5 mL, intramuscular, a single dose |
| |
| Agrippal S1 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigen |
| Day 0 and Day 21 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity in subjects with a pre-vaccination HI antibody titer <1:80 | Day 0 and Day 21 post-vaccination | |
| Immunogenicity compared to control group | Day 21 post vaccination, 6 months post vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Woojoo Kim | Korea University Guro Hospital | Principal Investigator |
| Seongheon Wie | Saint Vincent's Hospital, Korea | Principal Investigator |
| Shinwoo Kim | Kyungpook National University Hospital | Principal Investigator |
| Wonsuk Lee | Korea University Ansan Hospital | Principal Investigator |
| Jinsoo Lee | Inha University Hospital | Principal Investigator |
| Jacob Lee | Hallym University Kangnam Sacred Heart Hospital | Principal Investigator |
| Heungjeong Woo | Dotal Sacred Heart Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26314625 | Derived | Song JY, Cheong HJ, Lee J, Woo HJ, Wie SH, Lee JS, Kim SW, Noh JY, Choi WS, Kim H, Kim KH, Kim WJ. Immunogenicity and safety of a cell culture-derived inactivated trivalent influenza vaccine (NBP607): A randomized, double-blind, multi-center, phase 3 clinical trial. Vaccine. 2015 Oct 5;33(41):5437-5444. doi: 10.1016/j.vaccine.2015.08.030. Epub 2015 Aug 24. |
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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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| Biological |
0.5 mL, intramuscular, a single dose |
|
| Long-term Immunogenicity | 6 months post-vaccination |
| Percentage of participants with Solicited Local Adverse Event (AE) | During 7 days post-vaccination |
| Percentage of participants with Solicited Systemic Adverse Event (AE) | During 7 days post-vaccination |
| Percentage of participants with Unsolicited Adverse Event (AE) | During 21 days post-vaccination |
| Percentage of participants with Severe Adverse Event (SAE) | During 6 months post-vaccination |
| Vital Sign | Body Temperature, Blood Pressure(SBP/DBP), Pulse | Day 0 and Day 21 post vaccination |
| Physical Examination | inspection, palpation (feel), percussion (tap to determine resonance characteristics), and auscultation (listen) | Day 0 and Day 21 post vaccination |
| Clinical Laboratory Tests | Blood test(CBC, Coagulation, Chemistry), Urinalysis | Day 0 and Day 21 post vaccination |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |