drugset / Trial / NCT05155579
Assessment of Safety and Immunogenicity of a Single Vial Presentation of R21/Matrix-M and Co-Administration With EPI Vaccines
Phase 1
Completed
594 enrolled
University of Oxford
Malaria Research and Training Center, Bamako, Mali · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
This is a Phase Ib trial conducted in Bougouni, Mali to evaluate the safety and immunogenicity of R21/Matrix-M in a single and two vial presentation, with different immunisation schedules, and when co-administered with EPI vaccines in African children.
Timeline
- Start
- 2022-05-14
- Primary completion
- 2025-05-27
- Completion
- 2025-05-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DTP-HB-Hib vaccine | Vaccine | — | — |
| Subject | Imovax | Vaccine | — | — |
| Subject | Matrix-M1 Adjuvant | Other / unclassified | 5 ug | — |
| Subject | Matrix-M1 Adjuvant | Other / unclassified | 50 ug | — |
| Subject | Measles-rubella | Vaccine | — | — |
| Subject | Polio Sabin | Vaccine | — | — |
| Subject | Prevnar 13 | Vaccine | — | — |
| Subject | Rotavirus | Vaccine | — | — |
| Subject | Yellow Fever | Vaccine | — | — |