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

NCT07286370 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 537

Last updated 2026-04-20

No results posted yet for this study

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

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2028-04-27
Completion
2028-04-27

Countries

  • The Gambia

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07286370 on ClinicalTrials.gov