drugset / Trial / NCT07509047
Age-descending Study to Evaluate the Safety and Immunogenicity of the Cholera Conjugate Vaccine in Adults and Children
Phase 2
Recruiting
390 enrolled
International Vaccine Institute
EuBiologics Co.,Ltd · collabMassachusetts General Hospital · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This phase II study is intended to determine the immunogenicity and safety of single dose and two doses of OSP:rTTHc cholera conjugate vaccine (CCV) with or without alum adjuvant. The study will guide the future dosing schedule and formulation of CCV (with or without Aluminum phosphate adjuvant) expected to be needed in adults and children in cholera-endemic region.
Timeline
- Start
- 2026-01-13
- Primary completion
- 2027-03
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Euvichol-Plus | Vaccine | 1.5 ml | Oral |
| Subject | OSP:rTTHc CCV | Vaccine | 25 ug | Intramuscular |
Indications
No indication recorded.