drugset / Trial / NCT02097472
Dose-Finding Study of S.Pneumoniae Whole Cell Vaccine Adsorbed to Alum (PATH-wSP) in Healthy Kenyan Adults and Toddlers
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this study is to assess the safety and tolerability of PATH-wSP, administered intramuscularly to healthy Kenyan adults and toddlers who have been primed with a pneumococcal conjugate vaccine (PCV). Additionally, the study will explore whether a measurable immune response is elicited when PATH-wSP is administered to healthy Kenyan adults and toddlers who have been primed with PCV.
Timeline
- Start
- 2014-04
- Primary completion
- 2015-12
- Completion
- 2015-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DTP-HB-Hib vaccine | Vaccine | 0.5 ml | Intramuscular |
| Subject | PATH-wSP | Vaccine | 300 ug | Intramuscular |
| Subject | PATH-wSP | Vaccine | 600 ug | Intramuscular |
| Subject | PATH-wSP | Vaccine | 1000 ug | Intramuscular |
| Subject | Synflorix | Vaccine | 0.5 ml | — |