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

Recruiting Phase 2 Interventional Study
Salmonella Infections
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
6 Weeks – 6 Months
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
537 (estimated)
Sponsor
GlaxoSmithKline · Industry
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About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: Participants must: 1. Have signed/thumb-printed, voluntary, informed consent provided for them by their parent/Legally Authorized Representative (LAR) prior to performance of any study-specific procedure. 2. Be a male or female infant aged 6 months (±2 weeks) or 6 weeks (+2 wee…
Contacts

US GSK Clinical Trials Call Center

877-379-3718

GSKClinicalSupportHD@gsk.com

CONTACT

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466

GSKClinicalSupportHD@gsk.com

CONTACT