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An Open-label Phase 2 Study to Evaluate the Safety and Immnogenicity of a Single Subcutaneous Injection of Quadrivalent TAK-850 in Healthy Adult Subjects
This clinical trial is a Phase 2 study of a single subcutaneous injection of TAK-850 for 22 days in healthy Japanese adults.
Details
| Lead sponsor | Takeda |
|---|---|
| Phase | Phase 2 |
| Status | WITHDRAWN |
| Start date | 2016-03 |
| Completion | 2016-04 |
Conditions
- Influenza Prevention
Interventions
- TAK-850
Primary outcomes
- Number of Participants with Adverse Events — Up to Day 22
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. - Seroprotection Rate of Hemagglutination Inhibition (HI) Antibody Titer (egg-derived antigen) — Day 22
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). - Seroconversion Rate of HI Antibody Titer (egg-derived antigen) — Day 22
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). - Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (egg-derived antigen) — Day 22
Countries
Japan