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RecruitingNCT07286370Updated Apr 20, 2026

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 interventional study of Low dose of iNTS-TCV and Full dose of iNTS-TCV in Salmonella Infections, sponsored by GlaxoSmithKline. Recruiting at 1 site in The Gambia. Open to participants aged 6 Weeks to 6 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention

From the registry’s dates

  • Started Apr 2026; still recruiting 7 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
537
Allocation
Randomized
Ages
6 Weeks to 6 Months
Sex
All
01

Study 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).

02

Conditions studied

  • Salmonella Infections

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Keywords

  • Salmonella-typhoid conjugate (iNTS-TCV) vaccine
  • Typhoid fever
  • Infants
  • Safety
  • Reactogenicity
  • Immunogenicity
03

In context

Typhoid Fever

76 studies on the registry are indexed under Typhoid Fever; 11 are open to participants now.

This study's planned enrollment of 537 is above the median of 147 across 65 interventional studies indexed under Typhoid Fever.

Browse Typhoid Fever studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.

Browse GlaxoSmithKline studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Weeks to 6 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Participants must:

  1. Have signed/thumb-printed, voluntary, provided for them by their parent/Legally Authorized Representative (LAR) prior to performance of any study-specific procedure.
  2. 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.
  3. Have a parent/LAR, who can and will comply with the requirements of the protocol.
  4. Healthy as established by medical history, clinical examination, and laboratory assessment.
  5. Have received all routine childhood vaccinations as per the age.
  6. Have been born at full term (>=37 weeks gestation) based on maternal report and additional antenatal records if available.
  7. 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.
  8. Have a readily identifiable place of residence within a reasonable travelling distance of the study site.
  9. Have a parent/LAR with a means of telephone contact.
  10. 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.

Exclusion criteria

Exclusion Criteria:

Participants must not:

  1. Have had a known infection with STm, SEn or S. Typhi.
  2. Have a history of allergic reactions to any prior vaccination or components of the or control vaccines.
  3. to latex.
  4. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
  5. Have any history of anaphylaxis or other life-threatening allergic reactions.
  6. Have any confirmed or suspected congenital or acquired or immunodeficient condition, based on medical history and physical examination.
  7. Have any acute or chronic, 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.
  8. 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.
  9. 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).
  10. Have clinically significant (moderate in severity) acute illness on the day of vaccination (temporary exclusion if remains age-eligible within the allowed dosing window).
  11. 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.
  12. Have , , or based on baseline serological assessment (these serological evaluations are only required during the screening phase).
  13. 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).
  14. Have a positive rapid diagnostic test (RDT) (or blood film) for malaria (temporary exclusion if remains age-eligible).
  15. Have major congenital defects, as assessed by the Investigator.
  16. 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.
  17. Be malnourished at Screening Visit, defined as WHO weight for length Z-score less than -2 standard deviation (SD).
  18. Any other clinical condition that might pose additional risk to the participant as a result of participation in the clinical study.
  19. Have used traditional or local herbal medications, including topical medications, in the 14 days prior to enrollment

  20. 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.

    1. for , 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.
    2. long-acting immune-modifying drugs including among others immunotherapy (eg, TNF-inhibitors), monoclonal antibodies, antitumoral medication.
  21. Prior receipt of a typhoid vaccine, or an experimental iNTS or GMMA vaccine.
  22. 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.
  23. 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 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.
  24. 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.
  25. 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).
  26. 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.
  27. Any study personnel or their immediate dependents, family, or household members.
  28. Have plans to travel outside the study area for an extended duration during the period of study participation.
  29. Child in care.
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
537 participants (estimated)

Study arms

  • 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.

    Biological: Low dose of iNTS-TCV

  • 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.

    Biological: TYPHIBEV · Combination Product: Prevenar 13 · Combination Product: Nimenrix

  • 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.

    Biological: Full dose of iNTS-TCV

  • 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.

    Biological: Full dose of iNTS-TCV · Combination Product: Prevenar 13

  • 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.

    Biological: TYPHIBEV · Combination Product: Prevenar 13 · Combination Product: Nimenrix

  • 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.

    Biological: Low dose of iNTS-TCV

  • 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

    Biological: TYPHIBEV · Combination Product: Nimenrix

  • 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.

    Biological: Full dose of iNTS-TCV

  • 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

    Biological: TYPHIBEV · Combination Product: Nimenrix

  • 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.

    Biological: Low dose of iNTS-TCV

  • 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.

    Biological: Low dose of iNTS-TCV · Drug: Saline

  • 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.

    Biological: Full dose of iNTS-TCV

  • 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.

    Biological: Full dose of iNTS-TCV · Drug: Saline

  • 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

    Biological: TYPHIBEV · Combination Product: Nimenrix

Interventions

  • BiologicalLow dose of iNTS-TCV

    Low dose of iNTS-TCV vaccine will be administered.

  • BiologicalFull dose of iNTS-TCV

    Full dose of iNTS-TCV vaccine will be administered.

  • BiologicalTYPHIBEV

    TYPHIBEV vaccine will be administered.

    Also known as: Typhoid Vi-CRM197 conjugate vaccine

  • Combination productPrevenar 13

    Prevenar 13 vaccine will be administered.

  • Combination productNimenrix

    Nimenrix vaccine will be administered.

    Also known as: meningococcal groups A, C, W-135 and Y conjugate vaccine

  • DrugSaline

    Saline will be administered.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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]

    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.

    Time frame: 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]

    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.

    Time frame: At Day 1, Day 85 and Day 337

  4. 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.

    Time frame: 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]

    Time frame: From the first study intervention administration (Day 1) until study end (Day 505).

  6. 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).

  7. 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

  8. 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

  9. 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

  10. Number of participants with SAEs [for infants 6 WOA]

    Time frame: 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]

    Time frame: From the first study intervention administration (Day 1) until study end (Day 400).

  12. 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).

  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]

    Time frame: At 28 days after the second study intervention administration (Day 113)

  14. GMC ratio of anti-Vi IgG [for infants 6 MOA]

    Time frame: 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]

    Time frame: At 28 days after the third study intervention administration (Day 260)

  16. GMC ratio of anti-Vi IgG [for infants 6 WOA]

    Time frame: At 28 days after the third study intervention administration (Day 260)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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)

  7. 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)

  8. 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)

07

Study locations

1 of 1 sites recruiting
  • GSK Investigational Site
    Banjul, The Gambia
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

Access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Data sharing details ↗ · www.gsk-studyregister.com

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07286370
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Dec 16, 2025
Start date
Apr 1, 2026
Primary completion
Apr 27, 2028 (estimated)
Completion
Apr 27, 2028 (estimated)
Last update
Apr 20, 2026

Study contacts

US GSK Clinical Trials Call Center
Contact
GSKClinicalSupportHD@gsk.com
877-379-3718
EU GSK Clinical Trials Call Center
Contact
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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