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

NCT05613205 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2025-01-24

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-28
Primary Completion
2023-12-06
Completion
2024-04-02

Countries

  • Belgium

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05613205 on ClinicalTrials.gov