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 range6 Weeks – 6 Months

SexALL

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.
✓. 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.

What they're measuring

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

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

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

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).

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).

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).

Trial details

NCT IDNCT07286370

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-04-27

Contact for this trial

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

View on ClinicalTrials.gov More Salmonella Infections trials

Plain-language summary

Who can participate

Age range6 Weeks – 6 Months

SexALL

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.
✓. 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.

What they're measuring

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

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

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

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).

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).

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).