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This study assesses immunogenicity and safety of NBP607-QIV to Agrippal which are indicated for active immunization for the prevention of influenza disease. Total of 675 subjects or above (450 subjects for NBP607-QIV arm and 225 subjects for Agrippal arm) of 6 to 35 months of age are enrolled, and each subject is administered with single or two doses of vaccines depending on previous vaccination history.
This is a multi-national, multi-center, randomized, double blinded, parallel-group study to assess the immunogenicity and safety of NBP607-QIV compared to Agrippal which are indicated for active immunization for the the prevention of influenza disease. Total of 675 subjects or above (450 subjects for NBP607-QIV arm and 225 subjects for Agrippal arm) of 6 to 35 months of age are enrolled. Each subject is administered with single or two doses of vaccines depending on previous vaccination history, and randomly assigned in 2:1 ratio.
Stratified randomization for trial site and age strata is used to achieve the balance of treatment assignment.
Total of three or five visits are scheduled depeding on dosing schedule. For subjects assigned to single-dose vaccination schedule, blood sampling is conducted for immunogenicity assessment before and 4 weeks after single vaccination at Visit 1 and 3 respectively. Safety is monitored 3 days, 4 weeks after vaccination through Visit 2* and 3 (* telephone contact). For subjects assigned to two-dose vaccination schedule, blood sampling is conducted before first vaccination and 4 weeks after second vaccination at Visit 1 and Visit 5 respectively. Safety is monitored 3 days, 4 weeks after each vaccination through Visit 2*, 3, 4*, and 5 (* telephone contact)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBP607-QIV | Experimental | One or two doses of 0.5mL of NBP607-QIV by intramuscular injection |
|
| Agrippal | Active Comparator | One or two doses of 0.25mL of Agrippal by intramuscular injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBP607-QIV | Biological | Purified inactivated influenza virus surface antigens of four strains (quadrivalent) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-vaccination GMT(Geometric Mean Titer) by HI(Hemagglutination-inhibition) assay for the common strains (A/H1N1, A/H3N2, and B/Victoria) | Post-vaccination GMT will be adjusted for pre-vaccination titer | 4 weeks after last IP(Investigational Product) vaccination |
| Seroconversion rate by HI assay for the common strains (A/H1N1, A/H3N2, and B/Victoria) | Seroconversion rate is defined as the proportion of subjects who meet either of the following criteria:
| 4 weeks after last IP(Investigational Product) vaccination |
| Seroconversion rate by HI assay for the exclusive strain (B/Yamagata) | Seroconversion rate is defined as the proportion of subjects who meet either of the following criteria:
| 4 weeks after last IP(Investigational Product) vaccination |
| GMR(Geometric mean ratio) by HI assay for the exclusive strain (B/Yamagata) | The fold-rise of the geometric mean HI titer from pre- to post-vaccination | 4 weeks after last IP(Investigational Product) vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotection rate by HI assay for all strains | Seroprotection rate is defined as the proportion of subjects whose post-vaccination HI titer increased to ≥1:40 | 4 weeks after last IP(Investigational Product) vaccination |
| CHMP(Committee for Medicinal Products for Human Use) criteria assessment for the common strains (A/H1N1, A/H3N2, and B/Victoria) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yun Kyung Kim, MD | Korea University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SK Bioscience | Gyeonggi-do | Seongnam-si | 13494 | South Korea |
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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) |
|
CHMP criteria for seroconversion rate, GMR(Geometric Mean Ratio) will be assessed |
| 4 weeks after last IP(Investigational Product) vaccination |
| Consistency of immunogenicity among countries | Post-vaccination GMT and seroconversion rate for the common strains (A/H1N1, A/H3N2, and B/Victoria), and CHMP criteria for seroconversion rate and GMR for the exclusive strain (B/Yamagata) will be assessed | 4 weeks after last IP(Investigational Product) vaccination |
| Percentage of participants with Adverse Events(AEs) | Incidence rate of Solicited AE, unsolicited AE, SAE(Serious Adverse Event) will be assessed | 7 days for Solicited AE and 4 weeks for Unsolicited AE, SAE after last IP(Investigational Product) vaccination |
| Vital sign | Body temperature will be assessed | 4 weeks after last IP(Investigational Product) vaccination |
| Height | Height in centimeters will be assessed | 4 weeks after last IP(Investigational Product) vaccination |
| Weight | Weight in kilograms will be assessed | 4 weeks after last IP(Investigational Product) vaccination |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |