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This study assesses safety, tolerability and immunogenicity of NBP607QIV to Agrippal which are indicated for active immunization for the prevention of influenza disease.
Subjects are randomly assigned in a 1:1 ratio to NBP607QIV versus Agrippal S1. 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. To assess the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained at pre-vaccination and 21 days post-vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBP607QIV | Experimental | 1 dose of 0.5mL by Intramuscular injection |
|
| Agrippal | Active Comparator | 1 dose of 0.5mL by Intramuscular injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBP607QIV | Biological | Purified inactivated influenza virus surface antigens of four strains(quadrivalent) |
|
| 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. Comparisons within each group between pre-/post- vaccination were summarized and presented. The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated. | 7 days after vaccination |
| Incidence rate of solicited systemic AEs | The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated. | 7 days after vaccination |
| Incidence rate of unsolicited AEs | The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated. | 21 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotection rate measured by post-vaccination Haemagglutination Inhibition(HI) titer[Immunogenicity] | The proportion of subjects with post-vaccination HI titers of ≥1:40 | 21-28 days after vaccination |
| Seroconversion rate measured by pre-/post-vaccination HI titerImmunogenicity] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Woo Joo Kim, MD, PhD | Korea University Guro Hospital | Study Chair |
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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 | Biological | Influenza virus surface antigens of three strains(trivalent) |
|
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 |
| 9. 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 |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |