drugset / Trial / NCT07304284
Trial to Evaluate Immunogenicity Non-Inferiority, Safety and Lot-to-Lot Consistency of Biovac OCV-S to Euvichol®-Plus
Phase 3
Recruiting
2824 enrolled
International Vaccine Institute
BioVac · collabMedical Research Council, South Africa · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This Phase I/III clinical trial is intended to establish the immunogenicity and safety profile of Biovac OCV-S compared to available WHO pre-qualified vaccine Euvichol®-Plus in healthy adults and children and in adult people living with HIV (PLWH). The lot-to-lot consistency of Biovac OCV-S in healthy adults will also be determined.
Timeline
- Start
- 2025-10-31
- Primary completion
- 2026-12
- Completion
- 2027-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Biovac OCV-S | Vaccine | 1.5 ml | Oral |
| Comparator | Euvichol-Plus | Vaccine | 1.5 ml | Oral |
Indications
No indication recorded.