drugset / Trial / NCT05480800
A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella and Typhoid Fever
Phase 1/2
Completed
155 enrolled
GlaxoSmithKline
Bill and Melinda Gates Foundation · collabBiomedical Advanced Research and Development Authority · collabGlobal Antimicrobial Resistance Innovation Fund-(GAMRIF) · collabWellcome Trust · collab
RandomizedSequentialTriple-blindPrevention
Summary
The purpose of this study is to assess the safety, reactogenicity, and immune response induced by the GlaxoSmithKline Biologicals SA (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-typhoid conjugate (iNTS-TCV) candidate vaccine to be administered for the first time in humans. The study intervention will be evaluated in European adults in Stage 1 (a 2-step staggered design) followed by African adults in Stage 2.
Timeline
- Start
- 2022-09-13
- Primary completion
- 2024-09-02
- Completion
- 2025-01-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Meningococcal A, C, Y and W-135 conjugate vaccine | Vaccine | — | Intramuscular |
| Subject | Typhim Vi | Vaccine | — | Intramuscular |
| Comparator | Typhoid Conjugate vaccine | Vaccine | — | Intramuscular |
| Comparator | iNTS-GMMA | Vaccine | — | Intramuscular |
| Subject | iNTS-TCV | Vaccine | — | Intramuscular |
| Subject | tetanus toxoid | Vaccine | — | Intramuscular |