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NOT YET RECRUITING
NCT07286370
PHASE2

A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella Disease and Typhoid Fever in Infants

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

6 Weeks - 6 Months

Study Type

INTERVENTIONAL

Enrollment

537

Start Date

2026-02-16

Completion Date

2028-04-27

Last Updated

2026-01-21

Healthy Volunteers

Yes

Interventions

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.