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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
TAK-850 injection
Unnamed facility
Toshima-ku, Tokyo, Japan
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.
Time frame: 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).
Time frame: 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).
Time frame: Day 22
Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (egg-derived antigen)
Time frame: Day 22
Number of Participants who Meet the Markedly Abnormal Criteria for Vital Sign Measurements
Vital signs will include blood pressure, pulse rate and respiratory rate.
Time frame: Day 22
Number of Participants who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests
Laboratory tests will include hematology, biochemistry and urinalysis tests.
Time frame: Day 22
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Geometric Mean Titer (GMT) of HI Antibody Titer (egg-derived antigen)
Time frame: 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).
Time frame: 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).
Time frame: Day 22
GMFI in SRH Antibody Titer (egg-derived antigen)
Time frame: Day 22
GMT of SRH Antibody Titer (egg-derived antigen)
Time frame: 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).
Time frame: 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).
Time frame: Day 22
GMFI in HI Antibody Titer (cell-derived antigen)
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Day 22
GMFI in SRH Antibody Titer (cell-derived antigen)
Time frame: Day 22
GMT of SRH Antibody Titer (cell-derived antigen)
Time frame: Day 22