NCT05613205

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

A Phase 1, Observer-blind, Randomised, Controlled, Single-centre Study to Evaluate the Safety, Reactogenicity, and Immune Responses to an Adjuvanted and Non-adjuvanted Conjugate Vaccine Against Salmonella Typhi and Salmonella Paratyphi A in Healthy Adults 18 to 50 Years of Age in Europe

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Typhoid Fever

Interventions

Type	Name	Description
BIOLOGICAL	TYP04A Low Dose without Alum investigational vaccine	2 doses of TYP04A Low Dose without Alum investigational vaccine administered intramuscularly as a priming dose on Day 1 and a booster dose on Day 169.
BIOLOGICAL	TYP04B Full Dose without Alum investigational vaccine	2 doses of TYP04B Full Dose without Alum investigational vaccine administered intramuscularly as a priming dose on Day 1 and a booster dose on Day 169.
BIOLOGICAL	TYP03A Low Dose with Alum investigational vaccine	2 doses of TYP03A Low Dose with Alum investigational vaccine administered intramuscularly as a priming dose on Day 1 and a booster dose on Day 169.
BIOLOGICAL	TYP03B Full Dose with Alum investigational vaccine	2 doses of TYP03B Full Dose with Alum investigational vaccine administered intramuscularly as a priming dose on Day 1 and a booster dose on Day 169.
BIOLOGICAL	Sanofi Pasteur's Typhoid Vi polysaccharide vaccine	1 dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine administered intramuscularly, at Day 1, to participants in the control group.
BIOLOGICAL	GSK's Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine	1 dose of GSK's Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine administered intramuscularly, at Day 169, to participants in the control group.

Timeline

• Start date: 2022-11-28
• Primary completion: 2023-12-06
• Completion: 2024-04-02
• First posted: 2022-11-14
• Last updated: 2025-01-24
• Results posted: 2025-01-24

Locations

1 site across 1 country: Belgium