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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1178-8045 | Registry Identifier | WHO |
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This clinical trial is a Phase 2 study of a single subcutaneous injection of TAK-850 for 22 days in healthy Japanese adults.
The primary objective of this study is to evaluate the safety and immunogenicity of a single subcutaneous injection of TAK-850 for 22 days in healthy Japanese adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-850 0.5 mL | Experimental | TAK-850 0.5 mL (15 µg of hemagglutinin [HA] antigen per strain), subcutaneous injection, once on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-850 | Drug | TAK-850 injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment The adverse events will include solicited local and systemic AEs. | Up to Day 22 |
| Seroprotection Rate of Hemagglutination Inhibition (HI) Antibody Titer (egg-derived antigen) | Seroprotection Rate is defined as the percentage of participants with HI antibody titer ≥ 40 for each of the four strains (A/H1N1 strain, A/H3N2 strain, B/Yamagata strain, B/Victoria strain). | Day 22 |
| Seroconversion Rate of HI Antibody Titer (egg-derived antigen) | Seroconversion Rate is defined as the percentage of participants with a baseline HI antibody titer of ≥ 10 achieving a minimal 4-fold increase, or baseline HI antibody titer of < 10 achieving an HI antibody titer of ≥ 40 for each of the four strains (A/H1N1 strain, A/H3N2 strain, B/Yamagata strain, B/Victoria strain). | Day 22 |
| Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (egg-derived antigen) | Day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who Meet the Markedly Abnormal Criteria for Vital Sign Measurements | Vital signs will include blood pressure, pulse rate and respiratory rate. | Day 22 |
| Number of Participants who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toshima-ku | Tokyo | Japan |
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Laboratory tests will include hematology, biochemistry and urinalysis tests. |
| Day 22 |
| Geometric Mean Titer (GMT) of HI Antibody Titer (egg-derived antigen) | Day 22 |
| Seroprotection Rate of Single Radial Hemolysis (SRH) Antibody Titer (egg-derived antigen) | Seroprotection Rate is defined as the percentage of participants with SRH antibody titer ≥ 25 mm^2 for each of the four strains (A/H1N1 strain, A/H3N2 strain, B/Yamagata strain, B/Victoria strain). | Day 22 |
| Seroconversion Rate of SRH Antibody Titer (egg-derived antigen) | Seroconversion Rate is defined as the percentage of participants with a baseline SRH antibody titer of ≥ 4 mm^2 achieving a minimal 50 percent increase, or baseline HI antibody titer of < 4 mm^2 achieving an SRH antibody titer of ≥ 25 mm^2 for each of the four strains (A/H1N1 strain, A/H3N2 strain, B/Yamagata strain, B/Victoria strain). | Day 22 |
| GMFI in SRH Antibody Titer (egg-derived antigen) | Day 22 |
| GMT of SRH Antibody Titer (egg-derived antigen) | Day 22 |
| Seroprotection Rate of HI Antibody Titer (cell-derived antigen) | Seroprotection Rate is defined as the percentage of participants with HI antibody titer ≥ 40 for each of the four strains (A/H1N1 strain, A/H3N2 strain, B/Yamagata strain, B/Victoria strain). | Day 22 |
| Seroconversion Rate of HI Antibody Titer (cell-derived antigen) | Seroconversion Rate is defined as the percentage of participants with a baseline HI antibody titer of ≥ 10 achieving a minimal 4-fold increase, or baseline HI antibody titer of < 10 achieving an HI antibody titer of ≥ 40 for each of the four strains (A/H1N1 strain, A/H3N2 strain, B/Yamagata strain, B/Victoria strain). | Day 22 |
| GMFI in HI Antibody Titer (cell-derived antigen) | Day 22 |
| GMT of HI Antibody Titer (cell-derived antigen) | GMT of HI antibody titer for each of the four strains (A/H1N1 strain, A/H3N2 strain, B/Yamagata strain, B/Victoria strain), 21 days after vaccination. | Day 22 |
| Seroprotection Rate of SRH Antibody Titer (cell-derived antigen) | Seroprotection Rate is defined as the percentage of participants with SRH antibody titer ≥ 25 mm^2 for each of the four strains (A/H1N1 strain, A/H3N2 strain, B/Yamagata strain, B/Victoria strain). | Day 22 |
| Seroconversion Rate of SRH Antibody Titer (cell-derived antigen) | Seroconversion Rate is defined as the percentage of participants with a baseline SRH antibody titer of ≥ 4 mm^2 achieving a minimal 50 percent increase, or baseline HI antibody titer of < 4 mm^2 achieving an SRH antibody titer of ≥ 25 mm^2 for each of the four strains (A/H1N1 strain, A/H3N2 strain, B/Yamagata strain, B/Victoria strain). | Day 22 |
| GMFI in SRH Antibody Titer (cell-derived antigen) | Day 22 |
| GMT of SRH Antibody Titer (cell-derived antigen) | Day 22 |