drugset / Trial / NCT06663436
A Study on the Immune Response and Safety of a Multicomponent Shigella Vaccine in Preventing Shigellosis in Infants
RandomizedParallel-groupSingle-blindPrevention
Summary
This study evaluates the immune response and safety of a multicomponent, 2-dose Shigella vaccine in preventing shigellosis in African infants. The candidate vaccine, altSonflex1-2-3, is currently being evaluated in a Phase 2 age de-escalation (from least vulnerable adult population to most vulnerable paediatric population) clinical study in Kenya, with the aim of identifying a preferred dose, using a 3-dose vaccination schedule in infants from 9 months of age (NCT05073003). This Phase 2 clinical study will evaluate the safety and immunogenicity of an alternative 2-dose vaccination schedule.
Timeline
- Start
- 2024-11-13
- Primary completion
- 2025-10-21
- Completion
- 2025-10-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AltSonflex1-2-3 | Vaccine | — | Intramuscular |
| Comparator | TYPHIBEV | Vaccine | — | Intramuscular |
| Background | Infanrix hexa | Vaccine | — | Intramuscular |
| Background | MR-Vac | Vaccine | — | Subcutaneous |