CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 97 enrolled
Drug / intervention
TYP04A Low Dose without Alum investigational vaccine +5 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05613205
NCT05613205Phase 1Completed
CompareCT.gov

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

GlaxoSmithKline·interventional·Posted Nov 14, 2022·Updated Jan 24, 2025

In Brief

A Phase 1 clinical trial evaluating TYP04A Low Dose without Alum investigational vaccine, TYP04B Full Dose without Alum investigational vaccine, and 4 other interventions for Typhoid Fever. Completed, enrolled 97 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTyphoid Fever
CountriesBelgium
CollaboratorsBiological E. Limited

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedNov 14, 2022
Enrollment StartNov 28, 2022
Primary CompletionDec 6, 2023
Study CompletionApr 2, 2024
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 3.6 years ago

Interventions

TYP04A Low Dose without Alum investigational vaccinebiological

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.

TYP04B Full Dose without Alum investigational vaccinebiological

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.

TYP03A Low Dose with Alum investigational vaccinebiological

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.

TYP03B Full Dose with Alum investigational vaccinebiological

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.

Sanofi Pasteur's Typhoid Vi polysaccharide vaccinebiological

1 dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine administered intramuscularly, at Day 1, to participants in the control group.

GSK's Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccinebiological

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.