RecruitingPhase 2NCT07286370

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


Sponsor

GlaxoSmithKline

Enrollment

537 participants

Start Date

Apr 1, 2026

Study Type

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

Min Age: 6 WeeksMax Age: 6 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Full dose of iNTS-TCV, a biological treatment called Low dose of iNTS-TCV, and others for people with salmonella infections. The study is currently recruiting participants at 1 location. People eligible for this study include aged 6 Weeks to 6 Months.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALLow dose of iNTS-TCV

Low dose of iNTS-TCV vaccine will be administered.

BIOLOGICALFull dose of iNTS-TCV

Full dose of iNTS-TCV vaccine will be administered.

BIOLOGICALTYPHIBEV

TYPHIBEV vaccine will be administered.

COMBINATION_PRODUCTPrevenar 13

Prevenar 13 vaccine will be administered.

COMBINATION_PRODUCTNimenrix

Nimenrix vaccine will be administered.

DRUGSaline

Saline will be administered.


Locations(1)

GSK Investigational Site

Banjul, The Gambia

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NCT07286370


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