Salmonella InfectionsPhase 2NCT07286370
A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella Disease and Typhoid Fever in Infants
A Phase 2 study testing Low dose of iNTS-TCV, Full dose of iNTS-TCV and TYPHIBEV in people with Salmonella Infections, run by GlaxoSmithKline at 1 site in The Gambia.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 weeks to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Salmonella Infections
- What is being tested?
- Low dose of iNTS-TCV, Full dose of iNTS-TCV and TYPHIBEV
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 537 participants
- Where
- 1 siteThe Gambia
- Study dates
- 1 Apr 2026to 27 Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 weeks to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- Participants must not:
- 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.
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- 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.
- Have a documented fever (axillary temperature ≥37.5ºC) at the time of enrollment/dosing or within the 48 hours preceding dosing (temporary exclusion if remains age-eligible/within the allowed interval of dosing).
- Have clinically significant (moderate in severity) acute illness on the day of vaccination (temporary exclusion if remains age-eligible within the allowed dosing window).
- Have any screening/last pre-dosing safety laboratory test (if applicable) with a toxicity score of ≥3 or a value judged to be clinically significant by the study clinician.
- Have HIV, hepatitis B, or hepatitis C based on baseline serological assessment (these serological evaluations are only required during the screening phase).
- Be known to have been vertically exposed to HIV based on maternal history and baseline serological assessment in the participant (maternal screening for HIV will not be undertaken).
- Have a positive rapid diagnostic test (RDT) (or blood film) for malaria (temporary exclusion if remains age-eligible).
- Have major congenital defects, as assessed by the Investigator.
- Recurrent history or uncontrolled neurological disorders or any neuroinflammatory (including, but not limited to demyelinating disorders, encephalitis or myelitis of any origin), congenital neurological conditions, encephalopathies, or any history of seizures.
- Be malnourished at Screening Visit, defined as WHO weight for length Z-score less than -2 standard deviation (SD).
- Any other clinical condition that might pose additional risk to the participant as a result of participation in the clinical study.
- Have used traditional or local herbal medications, including topical medications, in the 14 days prior to enrollment
- Have a history of chronic administration of immune-modifying drugs (defined as more than 14 consecutive days) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study.
- for corticosteroids, this will mean prednisone equivalent >=0.5mg/kg/day with maximum of 20 mg/day for pediatric participants). The use of inhaled/per nasal and topical steroids are allowed.
- long-acting immune-modifying drugs including among others immunotherapy (eg, TNF-inhibitors), monoclonal antibodies, antitumoral medication.
- Prior receipt of a typhoid vaccine, or an experimental iNTS or GMMA vaccine.
- Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study intervention during the period starting 28 days before the first dose of study intervention (Day -28 to Day 1), or planned use during the study period.
- A vaccine not foreseen by the study protocol administered during the period starting at 14 days before the first dose and ending 14 days after the last dose of study interventions administration for live vaccines or 7 days in case of inactivated vaccines, with the exception of flu vaccines or Coronavirus disease 2019 (COVID-19) vaccine which may be considered on a case-by-case basis.
- Have been administered immunoglobulins and/or any blood products or plasma derivatives, or bone marrow transplantation, during the period starting 3 months before the first dose of study interventions or planned administration during the study period.
- Concurrently participating in another interventional clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non investigational intervention (drug or invasive medical device).
- Have any other factor which, in the opinion of the Investigator, might pose additional risk to the participant or substantially compromise data quality or the evaluation of study endpoints.
- Any study personnel or their immediate dependents, family, or household members.
- Have plans to travel outside the study area for an extended duration during the period of study participation.
- Child in care.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Gambia1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Banjul
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: 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).
- Conditions
- Salmonella Infections
- Being tested
- Low dose of iNTS-TCV, Full dose of iNTS-TCV, TYPHIBEV, Prevenar 13, Nimenrix
- Keywords
- Salmonella-typhoid conjugate (iNTS-TCV) vaccine, Typhoid fever, Infants, Safety, Reactogenicity, Immunogenicity
- Medical subject headings
- Salmonella Infections, Typhoid Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose of iNTS-TCVBiological
Low dose of iNTS-TCV vaccine will be administered.
Full dose of iNTS-TCVBiological
Full dose of iNTS-TCV vaccine will be administered.
TYPHIBEVBiological
Also called Typhoid Vi-CRM197 conjugate vaccine
TYPHIBEV vaccine will be administered.
Prevenar 13Combination product
Prevenar 13 vaccine will be administered.
NimenrixCombination product
Also called meningococcal groups A, C, W-135 and Y conjugate vaccine
Nimenrix vaccine will be administered.
SalineDrug
Saline will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Step 1a- Group 1 iNTS-TCV low dose (6 MOA) | Experimental | Participants 6 MOA receive 3 doses of a low dose of iNTS-TCV at Day 1, Day 85 and Day 337. Receives: Biological: Low dose of iNTS-TCV |
| Step 1a Group 2- Control group (6MOA) | Active comparator | Participants 6 MOA receive TYPHIBEV at Day 1, pneumococcal polysaccharide conjugate vaccine (13 valent) (Prevenar 13) at Day 85, and Nimenrix at Day 337. Receives: Biological: TYPHIBEV; Combination Product: Prevenar 13; Combination Product: Nimenrix |
| Step 1b Group 3- iNTS-TCV full dose (6 MOA) | Experimental | Participants 6 MOA receive 3 doses of a full dose of iNTS-TCV at Day 1, Day 85 and Day 337. Receives: Biological: Full dose of iNTS-TCV |
| Step 1b Group 4- iNTS-TCV full dose + Prevenar 13 (6 MOA) | Experimental | 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. Receives: Biological: Full dose of iNTS-TCV; Combination Product: Prevenar 13 |
| Step 1b Group 5- Control Group (6 MOA) | Active comparator | Participants 6 MOA receive TYPHIBEV at Day 1, Prevenar 13 at Day 85, and Nimenrix at Day 337. Receives: Biological: TYPHIBEV; Combination Product: Prevenar 13; Combination Product: Nimenrix |
| Step 1c- Group 6- iNTS-TCV low dose (6 WOA) | Experimental | Participants 6 WOA receive 3 doses of a low dose of iNTS-TCV at Day 1, Day 57 and Day 232. Receives: Biological: Low dose of iNTS-TCV |
| Step 1c- Group 7- Control Group (6 WOA) | Active comparator | Participants 6 WOA receive 2 doses of Nimenrix at Day 1 and Day 57, and 1 dose of TYPHIBEV at Day 232 Receives: Biological: TYPHIBEV; Combination Product: Nimenrix |
| Step 1d- Group 8- iNTS-TCV full dose (6 WOA) | Experimental | Participants 6 WOA receive 3 doses of a full dose of iNTS-TCV at Day 1, Day 57 and Day 232. Receives: Biological: Full dose of iNTS-TCV |
| Step 1d- Group 9- Control Group (6 WOA) | Active comparator | Participants 6 WOA receive 2 doses of Nimenrix at Day 1 and Day 57, and 1 dose of TYPHIBEV at Day 232 Receives: Biological: TYPHIBEV; Combination Product: Nimenrix |
| Step 2- Group 10- iNTS-TCV low dose (6 WOA) | Experimental | Participants 6 WOA receive 3 doses of a low dose of iNTS-TCV at Day 1, Day 57 and Day 232. Receives: Biological: Low dose of iNTS-TCV |
| Step 2- Group 11- iNTS-TCV low dose+ Saline Group (6 WOA) | Experimental | 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. Receives: Biological: Low dose of iNTS-TCV; Drug: Saline |
| Step 2- Group 12- iNTS-TCV full dose (6 WOA) | Experimental | Participants 6 WOA receive 3 doses of a full dose of iNTS-TCV at Day 1, Day 57 and Day 232. Receives: Biological: Full dose of iNTS-TCV |
| Step 2- Group 13- iNTS-TCV full dose+ Saline Group (6 WOA) | Experimental | 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. Receives: Biological: Full dose of iNTS-TCV; Drug: Saline |
| Step 2- Group 14 - Control Group (6 WOA) | Active comparator | Participants 6 WOA receive 2 doses of Nimenrix at Day 1 and Day 57, and 1 dose of TYPHIBEV at Day 232 Receives: Biological: TYPHIBEV; Combination Product: Nimenrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with solicited administration site events during 7 days after each study intervention administration [for infants 6 MOA]
Solicited administration site events included pain, redness, and swelling.
Measured: At Day 1, Day 85 and Day 337
Number of participants with solicited systemic events during 7 days after each study intervention administration [for infants 6 MOA]
Solicited systemic events included Fever, Irritability/Fussiness, Loss of appetite, Somnolence (sleepiness/drowsiness) and Vomiting. Fever is defined as body temperature more than or equal to (>=) 37.5 degrees Celsius (°C), measured from axilla.
Measured: At Day 1, Day 85 and Day 337
Number of participants with unsolicited adverse events (AEs) during 28 days after each study intervention administration [for infants 6 MOA]
An unsolicited AE is defined as an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Measured: At Day 1, Day 85 and Day 337
Number of participants with serious adverse events (SAEs) [for infants 6 MOA]
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
Measured: From the first study intervention administration (Day 1) until study end (Day 505).
Number of participants with AEs/SAEs leading to withdrawal from the study or discontinuation of study intervention [for infants 6 MOA]
Measured: From the first study intervention administration (Day 1) until study end (Day 505).
Number of participants with laboratory abnormalities [for infants 6 MOA]
Measured: At 7 days after each study intervention administration (Day 8, Day 92 and Day 344).
Number of participants with solicited administration site events during 7 days after each study intervention administration [for infants 6 WOA]
Measured: At Day 1, Day 57 and Day 232
Number of participants with solicited systemic events during 7 days after each study intervention administration [for infants 6 WOA]
Measured: At Day 1, Day 57 and Day 232
Number of participants with unsolicited adverse events (AEs) during 28 days after each study intervention administration [for infants 6 WOA]
Measured: At Day 1, Day 57 and Day 232
Number of participants with SAEs [for infants 6 WOA]
Measured: From the first study intervention administration (Day 1) until study end (Day 400).
Number of participants with AEs/SAEs leading to withdrawal from the study or discontinuation of study intervention [for infants 6 WOA]
Measured: From the first study intervention administration (Day 1) until study end (Day 400).
Number of participants with laboratory abnormalities [for infants 6 WOA]
Measured: At 7 days after each study intervention administration (Day 8, Day 64 and Day 239).
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]
Measured: At 28 days after the second study intervention administration (Day 113)
GMC ratio of anti-Vi IgG [for infants 6 MOA]
Measured: At 28 days after the first study intervention administration (Day 29)
GMC ratio of anti-STm and anti-SEn OAg IgG concentrations [for infants 6 WOA]
Measured: At 28 days after the third study intervention administration (Day 260)
GMC ratio of anti-Vi IgG [for infants 6 WOA]
Measured: At 28 days after the third study intervention administration (Day 260)
Secondary outcomes (8)
GMC of anti-STm OAg, anti-SEn OAg and anti-Vi IgG before each study intervention administration [for infants 6 MOA]
Measured: At Day 1, Day 85 and Day 337
GMC of anti-STm OAg, anti-SEn OAg and anti-Vi IgG 28 days after each study intervention administration [for infants 6 MOA]
Measured: At Day 29, Day 113 and Day 365
GMC of anti-STm OAg, anti-SEn OAg and anti-Vi IgG before each study intervention administration [for infants 6 WOA]
Measured: At Day 1, Day 57 and Day 232
GMC of anti-STm OAg, anti-SEn OAg and anti-Vi IgG 28 days after each study intervention administration [for infants 6 WOA]
Measured: At Day 29, Day 85 and Day 260
Number of participants achieving at least 2-fold and 4fold increase in antiserotype specific IgG concentrations [for infants 6 MOA]
Measured: At 28 days after each study intervention administration (Day 29, Day 113 and Day 365) compared with before the first study intervention administration (Day 1)
Number of participants with anti-Vi IgG concentrations greater than or equal to (>=)2.0 micrograms per milliliter (µg/mL) and >=4.3 µg/mL [for infants 6 MOA]
Measured: Before each study intervention administration (Day 1, Day 85 and Day 337) and 28 days after each study intervention administration (Day 29, Day 113 and Day 365)
Number of participants achieving at least 2-fold and 4fold increase in antiserotype specific IgG concentrations [for infants 6 WOA]
Measured: At 28 days after each study intervention administration (Day 29, Day 85 and Day 260), compared with before the first study intervention administration (Day 1)
Number of participants with anti-Vi IgG concentrations >=2.0 µg/mL and >=4.3 µg/mL [for infants 6 WOA]
Measured: Before each study intervention administration (Day 1, Day 57 and Day 232) and 28 days after each study intervention administration (Day 29, Day 85 and Day 260)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Apr 2026
- Primary completion27 Apr 2028 (estimated)
- Study completion27 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salmonella InfectionsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 537 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286370
- Sponsor's protocol ID
- 223550
- Status last verified
- Apr 2026
- First submitted
- 2 Dec 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07286370
- Acronym / sponsor ID
- 223550
- Conditions
- Salmonella Infections
- Keywords
- Salmonella-typhoid conjugate (iNTS-TCV) vaccine, Typhoid fever, Infants, Safety, Reactogenicity, Immunogenicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 537 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 27 Apr 2028 (estimated)
- Study completion
- 27 Apr 2028 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Step 1a- Group 1 iNTS-TCV low dose (6 MOA) | Experimental | Biological: Low dose of iNTS-TCVParticipants 6 MOA receive 3 doses of a low dose of iNTS-TCV at Day 1, Day 85 and Day 337. |
| Step 1a Group 2- Control group (6MOA) | Active comparator | Biological: TYPHIBEV, Combination Product: Prevenar 13, Combination Product: NimenrixParticipants 6 MOA receive TYPHIBEV at Day 1, pneumococcal polysaccharide conjugate vaccine (13 valent) (Prevenar 13) at Day 85, and Nimenrix at Day 337. |
| Step 1b Group 3- iNTS-TCV full dose (6 MOA) | Experimental | Biological: Full dose of iNTS-TCVParticipants 6 MOA receive 3 doses of a full dose of iNTS-TCV at Day 1, Day 85 and Day 337. |
| Step 1b Group 4- iNTS-TCV full dose + Prevenar 13 (6 MOA) | Experimental | Biological: Full dose of iNTS-TCV, Combination Product: Prevenar 13Participants 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. |
| Step 1b Group 5- Control Group (6 MOA) | Active comparator | Biological: TYPHIBEV, Combination Product: Prevenar 13, Combination Product: NimenrixParticipants 6 MOA receive TYPHIBEV at Day 1, Prevenar 13 at Day 85, and Nimenrix at Day 337. |
| Step 1c- Group 6- iNTS-TCV low dose (6 WOA) | Experimental | Biological: Low dose of iNTS-TCVParticipants 6 WOA receive 3 doses of a low dose of iNTS-TCV at Day 1, Day 57 and Day 232. |
| Step 1c- Group 7- Control Group (6 WOA) | Active comparator | Biological: TYPHIBEV, Combination Product: NimenrixParticipants 6 WOA receive 2 doses of Nimenrix at Day 1 and Day 57, and 1 dose of TYPHIBEV at Day 232 |
| Step 1d- Group 8- iNTS-TCV full dose (6 WOA) | Experimental | Biological: Full dose of iNTS-TCVParticipants 6 WOA receive 3 doses of a full dose of iNTS-TCV at Day 1, Day 57 and Day 232. |
| Step 1d- Group 9- Control Group (6 WOA) | Active comparator | Biological: TYPHIBEV, Combination Product: NimenrixParticipants 6 WOA receive 2 doses of Nimenrix at Day 1 and Day 57, and 1 dose of TYPHIBEV at Day 232 |
| Step 2- Group 10- iNTS-TCV low dose (6 WOA) | Experimental | Biological: Low dose of iNTS-TCVParticipants 6 WOA receive 3 doses of a low dose of iNTS-TCV at Day 1, Day 57 and Day 232. |
| Step 2- Group 11- iNTS-TCV low dose+ Saline Group (6 WOA) | Experimental | Biological: Low dose of iNTS-TCV, Drug: SalineParticipants 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. |
| Step 2- Group 12- iNTS-TCV full dose (6 WOA) | Experimental | Biological: Full dose of iNTS-TCVParticipants 6 WOA receive 3 doses of a full dose of iNTS-TCV at Day 1, Day 57 and Day 232. |
| Step 2- Group 13- iNTS-TCV full dose+ Saline Group (6 WOA) | Experimental | Biological: Full dose of iNTS-TCV, Drug: SalineParticipants 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. |
| Step 2- Group 14 - Control Group (6 WOA) | Active comparator | Biological: TYPHIBEV, Combination Product: NimenrixParticipants 6 WOA receive 2 doses of Nimenrix at Day 1 and Day 57, and 1 dose of TYPHIBEV at Day 232 |
Who may qualify
- Ages
- 6 weeks to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose of iNTS-TCVLow dose of iNTS-TCV vaccine will be administered. | Biological | Step 1a- Group 1 iNTS-TCV low dose (6 MOA), Step 1c- Group 6- iNTS-TCV low dose (6 WOA), Step 2- Group 10- iNTS-TCV low dose (6 WOA), Step 2- Group 11- iNTS-TCV low dose+ Saline Group (6 WOA) |
| Full dose of iNTS-TCVFull dose of iNTS-TCV vaccine will be administered. | Biological | Step 1b Group 3- iNTS-TCV full dose (6 MOA), Step 1b Group 4- iNTS-TCV full dose + Prevenar 13 (6 MOA), Step 1d- Group 8- iNTS-TCV full dose (6 WOA), Step 2- Group 12- iNTS-TCV full dose (6 WOA), Step 2- Group 13- iNTS-TCV full dose+ Saline Group (6 WOA) |
| TYPHIBEVAlso: Typhoid Vi-CRM197 conjugate vaccineTYPHIBEV vaccine will be administered. | Biological | Step 1a Group 2- Control group (6MOA), Step 1b Group 5- Control Group (6 MOA), Step 1c- Group 7- Control Group (6 WOA), Step 1d- Group 9- Control Group (6 WOA), Step 2- Group 14 - Control Group (6 WOA) |
| Prevenar 13Prevenar 13 vaccine will be administered. | Combination product | Step 1a Group 2- Control group (6MOA), Step 1b Group 4- iNTS-TCV full dose + Prevenar 13 (6 MOA), Step 1b Group 5- Control Group (6 MOA) |
| NimenrixAlso: meningococcal groups A, C, W-135 and Y conjugate vaccineNimenrix vaccine will be administered. | Combination product | Step 1a Group 2- Control group (6MOA), Step 1b Group 5- Control Group (6 MOA), Step 1c- Group 7- Control Group (6 WOA), Step 1d- Group 9- Control Group (6 WOA), Step 2- Group 14 - Control Group (6 WOA) |
| SalineSaline will be administered. | Drug | Step 2- Group 11- iNTS-TCV low dose+ Saline Group (6 WOA), Step 2- Group 13- iNTS-TCV full dose+ Saline Group (6 WOA) |
Primary outcome
Number of participants with solicited administration site events during 7 days after each study intervention administration [for infants 6 MOA]
Time frame: At Day 1, Day 85 and Day 337
Solicited administration site events included pain, redness, and swelling.
Number of participants with solicited systemic events during 7 days after each study intervention administration [for infants 6 MOA]
Time frame: At Day 1, Day 85 and Day 337
Solicited systemic events included Fever, Irritability/Fussiness, Loss of appetite, Somnolence (sleepiness/drowsiness) and Vomiting. Fever is defined as body temperature more than or equal to (>=) 37.5 degrees Celsius (°C), measured from axilla.
Number of participants with unsolicited adverse events (AEs) during 28 days after each study intervention administration [for infants 6 MOA]
Time frame: At Day 1, Day 85 and Day 337
An unsolicited AE is defined as an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Number of participants with serious adverse events (SAEs) [for infants 6 MOA]
Time frame: From the first study intervention administration (Day 1) until study end (Day 505).
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
Number of participants with AEs/SAEs leading to withdrawal from the study or discontinuation of study intervention [for infants 6 MOA]
Time frame: From the first study intervention administration (Day 1) until study end (Day 505).
Number of participants with laboratory abnormalities [for infants 6 MOA]
Time frame: At 7 days after each study intervention administration (Day 8, Day 92 and Day 344).
Number of participants with solicited administration site events during 7 days after each study intervention administration [for infants 6 WOA]
Time frame: At Day 1, Day 57 and Day 232
Number of participants with solicited systemic events during 7 days after each study intervention administration [for infants 6 WOA]
Time frame: At Day 1, Day 57 and Day 232
Number of participants with unsolicited adverse events (AEs) during 28 days after each study intervention administration [for infants 6 WOA]
Time frame: At Day 1, Day 57 and Day 232
Number of participants with SAEs [for infants 6 WOA]
Time frame: From the first study intervention administration (Day 1) until study end (Day 400).
Number of participants with AEs/SAEs leading to withdrawal from the study or discontinuation of study intervention [for infants 6 WOA]
Time frame: From the first study intervention administration (Day 1) until study end (Day 400).
Number of participants with laboratory abnormalities [for infants 6 WOA]
Time frame: At 7 days after each study intervention administration (Day 8, Day 64 and Day 239).
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]
Time frame: At 28 days after the second study intervention administration (Day 113)
GMC ratio of anti-Vi IgG [for infants 6 MOA]
Time frame: At 28 days after the first study intervention administration (Day 29)
GMC ratio of anti-STm and anti-SEn OAg IgG concentrations [for infants 6 WOA]
Time frame: At 28 days after the third study intervention administration (Day 260)
GMC ratio of anti-Vi IgG [for infants 6 WOA]
Time frame: At 28 days after the third study intervention administration (Day 260)
8 secondary outcomes
GMC of anti-STm OAg, anti-SEn OAg and anti-Vi IgG before each study intervention administration [for infants 6 MOA]
Time frame: At Day 1, Day 85 and Day 337
GMC of anti-STm OAg, anti-SEn OAg and anti-Vi IgG 28 days after each study intervention administration [for infants 6 MOA]
Time frame: At Day 29, Day 113 and Day 365
GMC of anti-STm OAg, anti-SEn OAg and anti-Vi IgG before each study intervention administration [for infants 6 WOA]
Time frame: At Day 1, Day 57 and Day 232
GMC of anti-STm OAg, anti-SEn OAg and anti-Vi IgG 28 days after each study intervention administration [for infants 6 WOA]
Time frame: At Day 29, Day 85 and Day 260
Number of participants achieving at least 2-fold and 4fold increase in antiserotype specific IgG concentrations [for infants 6 MOA]
Time frame: At 28 days after each study intervention administration (Day 29, Day 113 and Day 365) compared with before the first study intervention administration (Day 1)
Number of participants with anti-Vi IgG concentrations greater than or equal to (>=)2.0 micrograms per milliliter (µg/mL) and >=4.3 µg/mL [for infants 6 MOA]
Time frame: Before each study intervention administration (Day 1, Day 85 and Day 337) and 28 days after each study intervention administration (Day 29, Day 113 and Day 365)
Number of participants achieving at least 2-fold and 4fold increase in antiserotype specific IgG concentrations [for infants 6 WOA]
Time frame: At 28 days after each study intervention administration (Day 29, Day 85 and Day 260), compared with before the first study intervention administration (Day 1)
Number of participants with anti-Vi IgG concentrations >=2.0 µg/mL and >=4.3 µg/mL [for infants 6 WOA]
Time frame: Before each study intervention administration (Day 1, Day 57 and Day 232) and 28 days after each study intervention administration (Day 29, Day 85 and Day 260)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low dose of iNTS-TCV, Full dose of iNTS-TCV and TYPHIBEV in people with Salmonella Infections, run by GlaxoSmithKline at 1 site in The Gambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in The Gambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with solicited administration site events during 7 days after each study intervention administration [for infants 6 MOA] (time frame: At Day 1, Day 85 and Day 337). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.