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A randomized, double-blinded, controlled, Phase I clinical trial to assess the safety, tolerability and immunogenicity of 'NBP607(trivalent inactivated cell-culture influenza vaccine)' compared to egg-based influenza vaccine in healthy adult volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | NBP607 0.5ml |
|
| Group 2 | Active Comparator | Agrippal 0.5ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBP607 | Biological | 1 dose, 0.5ml, Intramuscular (IM) injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of solicited local adverse events (AEs) | All AEs were classified and analyzed according to its severity and causality. The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated. | Within 21 days after vaccination |
| Incidence rate of solicited systemic AEs | All AEs were classified and analyzed according to its severity and causality. The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated. | Within 21 days after vaccination |
| Incidence rate of unsolicited AEs | All AEs were classified and analyzed according to its severity and causality. The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated. | Within 21 days after vaccination |
| Pulse rate at each visit | Comparisons within each group between pre-/post- vaccination were summarized and presented. | 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination |
| Blood pressure(systolic/diastolic) at each visit | Comparisons within each group between pre-/post- vaccination were summarized and presented. | 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination |
| Body temperature at each visit | Comparisons within each group between pre-/post- vaccination were summarized and presented. |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate measured by pre-/post-vaccination Haemagglutination Inhibition (HI) titer[Immunogenicity] | The proportion of subjects achieving one of the following conditions; i)If the pre-vaccination HI titer were <1:10, subjects achieving an HI titer ≥1:40 after vaccination ii)If the pre-vaccination HI titers were ≥1:10, subjects with a minimum 4-fold rise in HI titer | 21-28 days after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Woo Joo Kim, Ph.D. | Korea University Guro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | Guro-gu | 153-703 | South Korea |
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| Agrippal |
| Biological |
1 dose, 0.5ml, Intramuscular (IM) injection |
|
| 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination |
| Rate of normal/abnormal results in Electrocardiogram (ECG) (ventricular rate, PR interval, QRS, QT, and QTc) collected during screening visit and close-out visit | Comparisons within each group between pre-/post- vaccination were summarized and presented. | Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination) |
| Rate of normal/abnormal results in physical examination at each visit | Comparisons within each group between pre-/post- vaccination were summarized and presented. | 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination |
| Rate of normal/abnormal results in clinical laboratory tests(Platelet, Cl, etc.) during screening visit and close-out visit | Comparisons within each group between pre-/post- vaccination were summarized and presented. | Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination) |
| Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity] | The mean increase in geometric mean HI titer | 21-28 days after vaccination |
| Seroprotection rate measured by post-vaccination HI titer[Immunogenicity] | The proportion of subjects with post-vaccination HI titers of ≥1:40 | 21-28 days after vaccination |