A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against … (NCT07286370) | Clinical Trial Compass
RecruitingPhase 2
A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella Disease and Typhoid Fever in Infants
The Gambia537 participantsStarted 2026-04-01
Plain-language 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).
Who can participate
Age range
6 Weeks – 6 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with solicited administration site events during 7 days after each study intervention administration [for infants 6 MOA]
Timeframe: At Day 1, Day 85 and Day 337
2
Number of participants with solicited systemic events during 7 days after each study intervention administration [for infants 6 MOA]
Timeframe: At Day 1, Day 85 and Day 337
3
Number of participants with unsolicited adverse events (AEs) during 28 days after each study intervention administration [for infants 6 MOA]
Timeframe: At Day 1, Day 85 and Day 337
4
Number of participants with serious adverse events (SAEs) [for infants 6 MOA]
Timeframe: From the first study intervention administration (Day 1) until study end (Day 505).
5
Number of participants with AEs/SAEs leading to withdrawal from the study or discontinuation of study intervention [for infants 6 MOA]
Timeframe: From the first study intervention administration (Day 1) until study end (Day 505).
6
Number of participants with laboratory abnormalities [for infants 6 MOA]
Timeframe: At 7 days after each study intervention administration (Day 8, Day 92 and Day 344).
. 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.
Exclusion criteria
. Have had a known infection with STm, SEn or S. Typhi.
. Have a history of allergic reactions to any prior vaccination or components of the investigational or control vaccines.
. Hypersensitivity to latex.
. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
. Have any history of anaphylaxis or other life-threatening allergic reactions.
. Have any confirmed or suspected congenital or acquired immunosuppressive or immunodeficient condition, based on medical history and physical examination.
. Have any acute or chronic, clinically significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, or hematological abnormality or illness, as determined by medical history, physical examination, and (when applicable) baseline laboratory assessments. Known sickle cells disease (but not sickle cell trait) is an exclusion.
. Have a bleeding or coagulation disorder contraindicating intramuscular injections or any other condition that in the judgment of the Investigator would make intramuscular injection unsafe.
7
Number of participants with solicited administration site events during 7 days after each study intervention administration [for infants 6 WOA]
Timeframe: At Day 1, Day 57 and Day 232
8
Number of participants with solicited systemic events during 7 days after each study intervention administration [for infants 6 WOA]
Timeframe: At Day 1, Day 57 and Day 232
9
Number of participants with unsolicited adverse events (AEs) during 28 days after each study intervention administration [for infants 6 WOA]
Timeframe: At Day 1, Day 57 and Day 232
10
Number of participants with SAEs [for infants 6 WOA]
Timeframe: From the first study intervention administration (Day 1) until study end (Day 400).
11
Number of participants with AEs/SAEs leading to withdrawal from the study or discontinuation of study intervention [for infants 6 WOA]
Timeframe: From the first study intervention administration (Day 1) until study end (Day 400).
12
Number of participants with laboratory abnormalities [for infants 6 WOA]
Timeframe: At 7 days after each study intervention administration (Day 8, Day 64 and Day 239).
13
Geometric Mean concentration (GMC) ratio of anti- S. typhimurium (STm) and anti- Salmonella Enteritidis (SEn) O-antigen (OAg) immunoglobulin G (IgG) [for infants 6 MOA]
Timeframe: At 28 days after the second study intervention administration (Day 113)
14
GMC ratio of anti-Vi IgG [for infants 6 MOA]
Timeframe: At 28 days after the first study intervention administration (Day 29)
15
GMC ratio of anti-STm and anti-SEn OAg IgG concentrations [for infants 6 WOA]
Timeframe: At 28 days after the third study intervention administration (Day 260)
16
GMC ratio of anti-Vi IgG [for infants 6 WOA]
Timeframe: At 28 days after the third study intervention administration (Day 260)