Actively Recruiting
A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella Disease and Typhoid Fever in Infants
Led by GlaxoSmithKline · Updated on 2026-04-20
537
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella Disease and Typhoid Fever in Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent from parent or legal representative before any study procedure
- Male or female infant aged 6 months (±12 weeks) or 6 weeks (+2 weeks) at first vaccination
- Parent or guardian able to comply with study requirements
- Healthy based on medical history, exam, and lab tests
- Received all routine childhood vaccines appropriate for age
- Born at full term (≥37 weeks gestation) according to maternal report or records
- Parent or guardian agrees to avoid herbal or traditional medicines during study and consult study team before other medications
- Resides within reasonable travel distance to study site
- Parent or guardian has telephone contact
- Parent or guardian agrees to avoid vaccines not provided by study during enrollment; routine vaccines during study given by study team
You will not qualify if you...
- Previous known infection with Salmonella typhimurium, Salmonella Enteritidis, or Salmonella Typhi
- History of allergic reactions to prior vaccines or components
- Hypersensitivity to latex
- History of anaphylaxis or other severe allergic reactions
- Confirmed or suspected immunodeficiency or immunosuppressive condition
- Significant acute or chronic illness including pulmonary, cardiovascular, liver, gastrointestinal, kidney, neurological, or blood disorders
- Known sickle cell disease (not trait)
- Bleeding or coagulation disorders preventing intramuscular injection
- Fever ≥37.5°C at enrollment or within 48 hours before dosing
- Moderate acute illness on vaccination day
- Screening lab tests showing clinically significant abnormalities
- HIV, hepatitis B, or hepatitis C infection
- Known vertical exposure to HIV
- Positive malaria test
- Major congenital defects
- Recurrent or uncontrolled neurological disorders or history of seizures
- Malnourished based on WHO weight for length Z-score <-2 SD
- Use of herbal or traditional medicines within 14 days before enrollment
- Chronic or planned use of immune-modifying drugs exceeding 14 days
- Prior receipt of typhoid, experimental iNTS, or GMMA vaccines
- Use of investigational or non-registered products within 28 days before first dose or planned during study
- Unapproved vaccines within 14 days before first dose until 14 days after last dose (except flu or COVID-19 vaccines on case-by-case basis)
- Immunoglobulin, blood products, plasma derivatives, or bone marrow transplant within 3 months before first dose or planned during study
- Participation in another interventional clinical study
- Any condition posing additional risk or compromising data quality
- Study personnel or immediate family members
- Plans to travel outside study area during participation
- Child in care
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
GSK Investigational Site
Banjul, The Gambia
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
14
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