clinical trial · NCT05480800
A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella and Typhoid Fever
GlaxoSmithKline·phase2·completed·n = 155
Salmonella InfectionsInvasive nontyphoidal Salmonella-typhoid conjugate vaccine (iNTS-TCV) low doseInvasive nontyphoidal Salmonella-generalized modules for membrane antigens vaccine (iNTS-GMMA) low doseTyphoid conjugate vaccine (TCV) low doseInvasive nontyphoidal Salmonella-typhoid conjugate vaccine (iNTS-TCV) full doseInvasive nontyphoidal Salmonella-generalized modules for membrane antigens vaccine (iNTS-GMMA) full doseTyphoid conjugate vaccine (TCV) full doseGSK's Meningococcal A, C, Y and W-135 conjugate vaccineGSK's Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine
brief summary
The purpose of this study is to assess the safety, reactogenicity, and immune response induced by the GlaxoSmithKline Biologicals SA (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-typhoid conjugate (iNTS-TCV) candidate vaccine to be administered for the first time in humans. The study intervention will be evaluated in European adults in Stage 1 (a 2-step staggered design) followed by African adults in Stage 2.
started
Sep 13, 2022
primary completion
Sep 2, 2024
completion
Jan 7, 2025
last updated
Nov 28, 2025
official title
A Phase 1/2a, Observer-blind, Randomized, Controlled, Two-stage, Multi-country Study to Evaluate the Safety, Reactogenicity, and Immune Response of the Trivalent Vaccine Against Invasive Nontyphoidal Salmonella (iNTS) and Typhoid Fever in Healthy European and African Adults
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol