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
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
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 6 months
Healthy Volunteers: t
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‣ Participants must:
• 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.
• Be a male or female infant aged 6 months (±2 weeks) or 6 weeks (+2 weeks) of age at the time of the first study vaccination.
• Have a parent/LAR, who can and will comply with the requirements of the protocol.
• Healthy as established by medical history, clinical examination, and laboratory assessment.
• Have received all routine childhood vaccinations as per the age.
• Have been born at full term (\>=37 weeks gestation) based on maternal report and additional antenatal records if available.
• Have a parent/LAR who is willing to avoid the administration of local herbal/traditional medications (including topical treatments) throughout the study period and who is willing to consult, as applicable, the study team prior to the use on other medications including over the-counter medications not supplied by the study team (except in the case of an emergency) throughout the study period.
• Have a readily identifiable place of residence within a reasonable travelling distance of the study site.
• Have a parent/LAR with a means of telephone contact.
⁃ Have a parent/LAR who is willing to avoid vaccinations not provided by the study team throughout the participant's enrollment in the study. All routine Essential Programme on Immunization (EPI) vaccines due during the study (outside those given concurrently with the study vaccines/controls) will also be administered by the study team.
Locations
Other Locations
Gambia
GSK Investigational Site
RECRUITING
Banjul
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date:2026-04-01
Estimated Completion Date:2028-04-27
Participants
Target number of participants:537
Treatments
Experimental: Step 1a- Group 1 iNTS-TCV low dose (6 MOA)
Participants 6 MOA receive 3 doses of a low dose of iNTS-TCV at Day 1, Day 85 and Day 337.
Active_comparator: Step 1a Group 2- Control group (6MOA)
Participants 6 MOA receive TYPHIBEV at Day 1, pneumococcal polysaccharide conjugate vaccine (13 valent) (Prevenar 13) at Day 85, and Nimenrix at Day 337.
Experimental: Step 1b Group 3- iNTS-TCV full dose (6 MOA)
Participants 6 MOA receive 3 doses of a full dose of iNTS-TCV at Day 1, Day 85 and Day 337.
Experimental: Step 1b Group 4- iNTS-TCV full dose + Prevenar 13 (6 MOA)
Participants 6 MOA receive 2 doses of a full dose of iNTS-TCV at Day 1 and Day 337 and 1 dose of Prevenar 13 at Day 85.
Active_comparator: Step 1b Group 5- Control Group (6 MOA)
Participants 6 MOA receive TYPHIBEV at Day 1, Prevenar 13 at Day 85, and Nimenrix at Day 337.
Experimental: Step 1c- Group 6- iNTS-TCV low dose (6 WOA)
Participants 6 WOA receive 3 doses of a low dose of iNTS-TCV at Day 1, Day 57 and Day 232.
Active_comparator: Step 1c- Group 7- Control Group (6 WOA)
Participants 6 WOA receive 2 doses of Nimenrix at Day 1 and Day 57, and 1 dose of TYPHIBEV at Day 232
Experimental: Step 1d- Group 8- iNTS-TCV full dose (6 WOA)
Participants 6 WOA receive 3 doses of a full dose of iNTS-TCV at Day 1, Day 57 and Day 232.
Active_comparator: Step 1d- Group 9- Control Group (6 WOA)
Participants 6 WOA receive 2 doses of Nimenrix at Day 1 and Day 57, and 1 dose of TYPHIBEV at Day 232
Experimental: Step 2- Group 10- iNTS-TCV low dose (6 WOA)
Participants 6 WOA receive 3 doses of a low dose of iNTS-TCV at Day 1, Day 57 and Day 232.
Experimental: Step 2- Group 11- iNTS-TCV low dose+ Saline Group (6 WOA)
Participants 6 WOA receive 1 dose of a saline on Day 1 and 2 doses of low dose of iNTS-TCV at Day 57 and Day 232.
Experimental: Step 2- Group 12- iNTS-TCV full dose (6 WOA)
Participants 6 WOA receive 3 doses of a full dose of iNTS-TCV at Day 1, Day 57 and Day 232.
Experimental: Step 2- Group 13- iNTS-TCV full dose+ Saline Group (6 WOA)
Participants 6 WOA receive 1 dose of saline on Day 1 and 2 doses of full dose of iNTS-TCV at Day 57 and Day 232.
Active_comparator: Step 2- Group 14 - Control Group (6 WOA)
Participants 6 WOA receive 2 doses of Nimenrix at Day 1 and Day 57, and 1 dose of TYPHIBEV at Day 232