A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella Disease and Typhoid Fever in Infants
A Phase 2a, Observer-Blind, Randomized, Controlled, Age-De-Escalation, Single-center Interventional Study to Evaluate the Safety, Reactogenicity, and Immune Response of the GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella (iNTS) Disease and Typhoid Fever, Including Dose and Schedule Finding in Infants, in Africa
GlaxoSmithKline
537 participants
Apr 1, 2026
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate 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) vaccine in infants with the first dose administered at 6 months of age (MOA) or 6 weeks of age (WOA).
Eligibility
Plain Language Summary
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Interventions
Low dose of iNTS-TCV vaccine will be administered.
Full dose of iNTS-TCV vaccine will be administered.
TYPHIBEV vaccine will be administered.
Prevenar 13 vaccine will be administered.
Nimenrix vaccine will be administered.
Saline will be administered.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07286370