Active — Not RecruitingPhase 2

A Study on the Safety, Reactogenicity, and Immune Response to the GVGH iNTS-GMMA Vaccine Against Invasive Nontyphoidal Salmonella in Adults, Children, and Infants

Ghana215 participantsStarted 2024-01-15

Plain-language summary

The purpose of this study is to evaluate the safety, reactogenicity, and immune response of the GlaxoSmithKline (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-generalized modules for membrane antigens (iNTS-GMMA) candidate vaccine against S. Typhimurium and S. Enteritidis with an age de-escalation and dose escalation approach in African population, starting with adults (18-50 years of age), then in children (24-59 months of age) and finally in infants (9 months and 6 weeks of age). Infants are the target for primary vaccination from 6 weeks of age.

Who can participate

Age range

6 Weeks – 50 Years

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: All participants (adults, children, infants at 9 months of age and infants at 6 weeks of age) will be enrolled in the clinical site in Ghana and must satisfy ALL the following criteria at study entry: * Participants and/or participants' parent(s)/Legally Acceptable Representative(s) (LAR), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits). * Written or witnessed/thumb printed informed consent obtained from the participant/parent(s)/LAR(s) of the participant prior to performance of any study-specific procedure. * Healthy participants as established by medical history, clinical examination, and laboratory investigations. * Participants satisfying screening requirements. * Participants negative for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C. Adult participants must satisfy ALL the following criteria in the study entry: * A male or female between and including 18 and 50 years of age at the time of the first study intervention administration. * Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause. * Female participants of childbearing potential may be enrolled in the study, if the participant: * has practiced adequate contraception for 1 m…

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

Number of adult participants 18-50 years of age with solicited administration site events

Timeframe: During 7 days after the first study intervention administration occurring at Day 1

Number of adult participants 18-50 years of age with solicited administration site events

Timeframe: During 7 days after the second study intervention administration occurring at Day 57

Number of adult participants 18-50 years of age with solicited systemic events

Timeframe: During 7 days after the first study intervention administration occurring at Day 1

Number of adult participants 18-50 years of age with solicited systemic events

Timeframe: During 7 days after the second study intervention administration occurring at Day 57

Number of adult participants 18-50 years of age with unsolicited adverse events (AEs)

Timeframe: During 28 days after the first study intervention administration occurring at Day 1

Number of adult participants 18-50 years of age with unsolicited adverse events (AEs)

Timeframe: During 28 days after the second study intervention administration occurring at Day 57

Trial details

NCT IDNCT06213506

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-30

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