drugset / Trial / NCT05613205
Safety and Immunogenicity of a Novel Conjugate Vaccine Against Salmonella Typhi and Salmonella Paratyphi A in Healthy Adults
RandomizedSequentialQuadruple-blindPrevention
Summary
A bivalent Typhoid and Paratyphoid A conjugate investigational vaccine aimed to prevent both typhoid and paratyphoid enteric fever in infants and older age groups has been developed by GlaxoSmithKline (GSK). The purpose of this first-time-in-human study is to evaluate the safety and immunogenicity profile of a low and a full dose of the investigational vaccine, formulated with or without adjuvant, administered in 2 doses, 24 weeks apart, in healthy adults 18 to 50 years of age in Europe.
Timeline
- Start
- 2022-11-28
- Primary completion
- 2023-12-06
- Completion
- 2024-04-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Boostrix | Vaccine | — | Intramuscular |
| Subject | TYP03A | Vaccine | — | Intramuscular |
| Subject | TYP03B | Vaccine | — | Intramuscular |
| Subject | TYP04A | Vaccine | — | Intramuscular |
| Subject | TYP04B | Vaccine | — | Intramuscular |
| Comparator | Typhim Vi | Vaccine | — | Intramuscular |