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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, reactogenicity, and immune response of the GlaxoSmithKline Biologicals SA (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-typhoid conjugate (iNTS-TCV) vaccine in infants. The study focuses on administering the first dose either at 6 months of age or at 6 weeks of age. This Phase 2a trial aims to find the appropriate dose and schedule for the vaccine to protect against invasive nontyphoidal Salmonella disease and typhoid fever in infants in Africa. The study involves multiple groups of infants receiving different vaccine schedules and doses. Infants aged 6 months receive three doses of either a low or full dose of iNTS-TCV vaccine on Day 1, Day 85, and Day 337, or combinations of other vaccines including TYPHIBEV, Prevenar 13, and Nimenrix. Infants aged 6 weeks receive similar dosing schedules but with adjusted timing at Day 1, Day 57, and Day 232, including some groups receiving saline doses. The study includes control groups receiving licensed vaccines for comparison. Participants will be closely monitored throughout the study for side effects at the injection site and systemically, with assessments occurring within 7 days after each vaccine dose. Safety monitoring continues for up to 505 days for infants starting at 6 months and 400 days for those starting at 6 weeks. Blood tests will measure immune responses before and after vaccinations, evaluating antibodies against Salmonella and typhoid antigens. The study includes detailed laboratory assessments and tracking of any adverse events or serious complications during the follow-up period.
CONDITIONS
Brief 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...
- Parent or legally authorized representative has given voluntary informed consent before any study procedures
- Infant is male or female aged 6 months (±12 weeks) or 6 weeks (+2 weeks) at first vaccination
- Parent or caregiver can comply with study requirements
- Infant is healthy based on medical history, exam, and lab tests
- Infant has received all routine childhood vaccines appropriate for age
- Infant was born at full term (≥37 weeks gestation) based on maternal report
- Parent will avoid herbal or traditional medications during the study and consult study team before other medications
- Infant lives within reasonable travel distance from study site
- Parent has telephone contact
- Parent agrees to avoid non-study vaccines during participation except routine essential immunizations given by study team
You will not qualify if you...
- History of infection with Salmonella Typhimurium, Salmonella Enteritidis, or S. Typhi
- Allergic reactions to previous vaccines or vaccine components
- Hypersensitivity to latex
- History of severe allergic reactions or anaphylaxis
- Known or suspected immunosuppressive or immunodeficient condition
- Significant acute or chronic illness including pulmonary, heart, liver, kidney, neurological, or blood disorders
- Bleeding or coagulation disorders contraindicating intramuscular injections
- Fever ≥37.5°C at enrollment or within 48 hours prior
- Moderate acute illness on vaccination day
- Abnormal lab tests with clinically significant toxicity
- Positive tests for HIV, hepatitis B or C, or malaria
- Major congenital defects
- Recurrent or uncontrolled neurological or neuroinflammatory disorders
- Malnutrition with weight for length Z-score less than -2 SD
- Use of herbal medications within 14 days prior to enrollment
- Chronic or planned use of immune-modifying drugs
- Prior receipt of typhoid or experimental Salmonella vaccines
- Use of investigational products within 28 days before first dose
- Receipt of non-study vaccines outside protocol window except flu or COVID-19 vaccines
- Blood or plasma product use within 3 months prior to first dose
- Participation in another interventional clinical study with investigational products
- Any condition posing additional risk or compromising data quality
- Study personnel or their immediate family members
- Plans to travel outside study area for extended time
- Child in care
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 11 months
Participants receive vaccine doses according to their assigned group, with doses administered on scheduled days over the course of approximately 11 months.
3 vaccination visits at Day 1, Day 57/85, and Day 232/337 depending on group assignment
Duration - Up to 12 months after last dose
Participants are monitored for safety and immune response up to the study end after the last vaccination.
Multiple follow-up visits for safety and immunogenicity assessments
Trial Site Locations
Total: 1 location
1
GSK Investigational Site
Banjul, The Gambia
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
14
Frequently Asked Questions
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