This clinical trial is a phase 1/2 study of a single intramuscular injection of TAK-850 in healthy Japanese adult participants
The primary objective of this study is to evaluate the safety and immunogenicity of a single intramuscular injection of TAK-850 for 22 days in healthy Japanese adults
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
TAK-850 injection
Unnamed facility
Sumida-ku, Tokyo, Japan
Number of Participants With Solicited Injection Site and Systemic Adverse Events
Number of participants with injection site and systemic adverse events will be tabulated in its own, and by severity and day of onset. Described if solicited adverse event term is different from the PT.
Time frame: For 22 days
Percentage of Participants With Seroprotection Rate of Hemagglutination Inhibition [HI] Antibody Titer
Seroprotection rate is measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroprotection Rate was defined as the percentage of participants with HI antibody titer ≥ 40 for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).
Time frame: Day 22
Seroconversion Rate of HI AntibodyTiter
Seroconversion rate is measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroconversion Rate was defined as the perccentage 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 three strains (A/H1N1 strain, A/H3N2 strain, B strain).
Time frame: Day 22
Geometric Mean Fold Increase in HI Antibody Titer
Geometric mean fold increase in HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared to baseline.
Time frame: Day 22
Change From Baseline in Blood Pressure
For continuous variables, summary statistics of measured values and respective changes from baseline will be calculated at each evaluation time point. In addition, figures illustrating individual changes will be created. For discrete variables, shift tables (before and after vaccination) will be created.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 1 (Baseline), Day 8, Day 22
Change From Baseline in Safety Electrocardiogram (ECG) Parameters
The ECG data will be analyzed into 3 categories, 'normal', 'abnormal but not clinically significant' and 'abnormal clinically significant'. Using these variables, shift tables (before and after vaccination) will be created by individual participant. . The definitions for the acronyms are as follows: Within Normal Limits (WNL), Not Clinically Significant (NCS), and Clinically Significant (CS).
Time frame: Day 1 and Day 22
Geometric Mean Titer (GMT) of HI Antibody Titer
Geometric mean titer (GMT) of HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination
Time frame: Day 22
GMT of Single Radial Hemolysis (SRH) Antibody Titer
GMT of single radial hemolysis (SRH) antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.
Time frame: Day 22
Seroprotection Rate of SRH Antibody Titer
Seroprotection rate is measured by SRH antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.
Time frame: Day 22
Seroconversion Rate of SRH Antibody Titer
Seroconversion rate as measured by SRH antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.
Time frame: Day 22
Geometric Mean Fold Increase in SRH Antibody Titer
Geometric mean fold increase in SRH antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared to baseline.
Time frame: Day 22