drugset / Trial / NCT02992925
Phase 3 Study of BK1310 in Healthy Infants
Phase 3
Completed
370 enrolled
Tanabe Pharma Corporation
The Research Foundation for Microbial Diseases of Osaka University · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this study is to: * (cohort 1) evaluate safety and immunogenicity (Haemophilus influenzae type b, Hib) of BK1310. * (cohort 2) evaluate efficacy and safety of BK1310 using ActHIB® and Tetrabik as a control in healthy infants.
Timeline
- Start
- 2016-11
- Primary completion
- 2017-12
- Completion
- 2018-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ActHIB | Vaccine | 0.5 ml | Subcutaneous |
| Comparator | DPT-IPV | Vaccine | 0.5 ml | Subcutaneous |
| Subject | DPT-IPV-Hib-High | Vaccine | 0.5 ml | Subcutaneous |
| Subject | DPT-IPV-Hib-Low | Vaccine | 0.5 ml | Subcutaneous |
Indications
No indication recorded.