drugset / Trial / NCT05613205

Safety and Immunogenicity of a Novel Conjugate Vaccine Against Salmonella Typhi and Salmonella Paratyphi A in Healthy Adults

NCT05613205

Phase 1 Completed 97 enrolled GlaxoSmithKline Biological E. Limited · collab
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

EvaluationDrugModalityDoseRoute
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

Indications