Overview

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 on children (24-59 months of age) and finally to infants (9 months and 6 weeks of age). Infants are the target for primary vaccination from 6 weeks of age.

Eligibility

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 at 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 month prior to study intervention
        administration, and:
          -  has a negative pregnancy test on the day of study intervention administration, and
          -  has agreed to continue adequate contraception during the entire treatment period and
             for 1 month after completion of the study intervention administration series.
        The Ghana card will be used as source document to verify the ages for the adults.
        Child participants must satisfy ALL the following criteria at study entry:
          -  A male or female between and including 24 and 59 months of age at the time of the
             first study intervention administration.
          -  Previously completed routine childhood vaccinations to the best knowledge of the
             participant's parent(s)/LAR's.
          -  Born after a gestation period of ≥37 weeks.
        Infant participants must satisfy ALL the following criteria at study entry:
          -  A male or female 6 weeks or 9 months of age at the time of the first study
             intervention administration.
          -  Born after a gestation period of ≥37 weeks.
          -  Born to a mother seronegative for HIV, hepatitis B virus and hepatitis C virus.
        The Road to Health Chart will be used as source document to confirm the ages for the
        children and infants.
        Exclusion criteria:
        Medical conditions
          -  Known exposure to S. Typhimurium or S. Enteritidis during the period starting at birth
             for infants and children, and at 3 years for adults, as documented by patient records
          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the study interventions.
          -  Hypersensitivity, including allergy, to medicinal products or medical equipment whose
             use is foreseen in this study.
          -  Progressive, unstable, or uncontrolled clinical conditions.
          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination
          -  Major congenital defects, as assessed by the investigator.
          -  Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal
             functional abnormality, as determined by physical examination or laboratory screening
             tests.
          -  Acute disease and/or fever at the time of enrollment (fever is defined as temperature
             ≥ 38.0°C).
          -  Recurrent history or uncontrolled neurological disorders or seizures.
          -  Any clinically significant hematological and/or biochemical laboratory abnormality.
          -  Undernutrition defined as WHO Z-score less than -2 SD.
          -  Malaria infection defined as the presence of asexual parasites in the blood.
          -  Clinical conditions representing a contraindication to intramuscular vaccination and
             blood draws.
          -  Any behavioral or cognitive impairment or psychiatric disease that, in the opinion of
             the investigator, may interfere with the participant's ability to participate in the
             study.
          -  Any other clinical condition that, in the opinion of the investigator, might pose
             additional risk to the participant due to participation in the study.
        Prior/Concomitant therapy
          -  History of receiving any investigational iNTS or GMMA vaccines in the participant's
             life.
          -  Use of any investigational or non-registered product other than the study
             interventions during the period beginning 30 days before the first dose of study
             interventions, or their planned use during the study period.
          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             in the period starting 14 days before each dose and ending 28 days after the last dose
             of study interventions administration, with the exception of flu vaccines and vaccines
             administered as part of a public health vaccination campaign.
          -  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 COVID-19 vaccine which may be
             considered on a case-by-case basis.
               -  If emergency mass vaccination for an unforeseen public health threat (e.g., a
                  pandemic) is organized by public health authorities outside the routine
                  immunization program, the time period described above can be reduced if, provided
                  it is used according to the local governmental recommendations and Sponsor is
                  notified.
        Under such circumstances, a participant may be considered eligible for study enrollment
        and/or study intervention administration after the appropriate window for delay has passed
        and inclusion/exclusion criteria have been re-checked, and if the participant is confirmed
        to be eligible.
          -  Administration of long-acting immune-modifying drugs at any time during the study
             period.
          -  Administration of immunoglobulins and/or any blood products or plasma derivatives from
             birth (for infant 6 weeks of age) or during the period starting 3 months before the
             administration of the first dose of study intervention(s) or planned administration
             during the study period.
          -  Chronic administration (defined as more than 14 days in total) of immunosuppressants
             or other immune-modifying drugs during the period starting 3 months prior to the first
             study intervention dose(s) up to the end of the study. For corticosteroids, this will
             mean prednisone equivalent greater than or equal to (>=) 20 mg/day for adult
             participants/ >= 0.5 mg/kg/day with maximum of 20 mg/day for pediatric participants
             (infants and children). Inhaled and topical steroids are allowed.
        Prior/Concurrent clinical study experience
        • Concurrently participating in another 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 (vaccine, drug and device).
        Other exclusions
          -  Pregnant or lactating female.
          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.
          -  History of/current chronic alcohol consumption and/or drug abuse. This will be decided
             at the discretion of the investigator.
          -  Any study personnel or their immediate dependents, family, or household members.
          -  Child in care.