NCT07286370

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 537 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 6 Months
• Healthy volunteers: Accepted

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).

Conditions

• Salmonella Infections

Interventions

Type	Name	Description
BIOLOGICAL	Low dose of iNTS-TCV	Low dose of iNTS-TCV vaccine will be administered.
BIOLOGICAL	Full dose of iNTS-TCV	Full dose of iNTS-TCV vaccine will be administered.
BIOLOGICAL	TYPHIBEV	TYPHIBEV vaccine will be administered.
COMBINATION_PRODUCT	Prevenar 13	Prevenar 13 vaccine will be administered.
COMBINATION_PRODUCT	Nimenrix	Nimenrix vaccine will be administered.
DRUG	Saline	Saline will be administered.

Timeline

• Start date: 2026-02-16
• Primary completion: 2028-04-27
• Completion: 2028-04-27
• First posted: 2025-12-16
• Last updated: 2026-01-21