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An Open-label Phase 1/2 Study to Evaluate the Safety and Immunogenicity of a Single Intramuscular Injection of TAK-850 in Healthy Adult Subjects
This clinical trial is a phase 1/2 study of a single intramuscular injection of TAK-850 in healthy Japanese adult participants
Details
| Lead sponsor | Takeda |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 55 |
| Start date | 2014-03 |
| Completion | 2014-04 |
Conditions
- Influenza
Interventions
- TAK-850
Primary outcomes
- Number of Participants With Solicited Injection Site and Systemic Adverse Events — For 22 days
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. - Percentage of Participants With Seroprotection Rate of Hemagglutination Inhibition [HI] Antibody Titer — Day 22
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). - Seroconversion Rate of HI AntibodyTiter — Day 22
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). - Geometric Mean Fold Increase in HI Antibody Titer — Day 22
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.
Countries
Japan