Invasive nontyphoidal Salmonella Paediatrics
Conditions
Interventions
iNTS GMMA Adults Dose C Group
MenACWY and placebo Adults Control Group
iNTS GMMA Children Dose B Group
MenACWY Children Control B Group
iNTS GMMA Children Dose C Group
MenACWY Children Control C Group
iNTS GMMA Infants 9M Dose A Group
MenACWY and DTPa HBV IPV Hib Infants 9M Control A Group
iNTS GMMA Infants 9M Dose B Group
MenACWY and DTPa HBV IPV Hib Infants 9M Control B Group
iNTS GMMA Infants 9M Dose C Group
MenACWY and DTPa HBV IPV Hib Infants 9M Control C Group
iNTS GMMA Infants 6W Dose A Group
MenACWY Infants 6W Control A Group
iNTS GMMA Infants 6W Dose B Group
MenACWY Infants 6W Control B Group
iNTS GMMA Infants 6W Dose C Group
MenACWY Infants 6W Control C Group
Sponsors
GlaxoSmithKline Biologicals SA GSK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All participants: • 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. Adults 18 to 50 years of age: • 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. • 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. Child participants: • 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: • 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.
Exclusion criteria
Exclusion criteria: • Known exposure to S. Typhimurium or S. Enteritidis during the period starting at birth for infants and children, and at 3 years for adults, • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions. • Hypersensitivity, including allergy, to medicinal products • Progressive, unstable, or uncontrolled clinical conditions. • Any confirmed or suspected immunosuppressive or immunodeficient condition • Major congenital defects • Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality • Acute disease and/or fever at the time of enrollment • uncontrolled neurological disorders or seizures • Any clinically significant hematological and/or biochemical laboratory abnormality. • Undernutrition • Malaria infection • Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. • Any behavioral or cognitive impairment or psychiatric disease. • Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study • Received any investigational iNTS or GMMA vaccines • Use of any investigational or non-registered product other than the study interventions • Planned administration/administration of a vaccine not foreseen by the study • 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 3 Mo before study start • Chronic administration of immunosuppressants/immune-modifying drugs from 3mo before 1st dose. • Concurrently participating in another interventional clinical study, • Pregnant or lactating female. • Female planning to become pregnant • History of/current chronic alcohol consumption and/or drug abuse. • Study personnel, their immediate dependents, family or household • Child in care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome measure 1 - Anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in infants 6 weeks of age part of the dose-finding cohort. Anti-Salmonella Typhimurium (S. Typhimurium) O antigen (Ag) total IgG and anti-Salmonella Enteritidis (S. Enteritidis) OAg total IgG GMCs are assessed. ;Outcome measure 2 - Percentage of adult participants 18–50 years of age with solicited administration site events after the first study intervention administration. The solicited administration site events are pain, redness and swelling.;Outcome measure 3 - Percentage of adult participants 18–50 years of age with solicited administration site events after the second study intervention administration. The solicited administration site events are pain, redness and swelling. ;Outcome measure 4 - Percentage of adult participants 18–50 years of age with solicited systemic events after the first study intervention administration. The solicited systemic events are fever, headache, myalgia, arthralgia and fatigue. ;Outcome measure 5 - Percentage of adult participants 18–50 years of age with solicited systemic events after the second study intervention administration. The solicited systemic events are fever, headache, myalgia, arthralgia and fatigue.;Outcome measure 6 - Percentage of adult participants 18–50 years of age with unsolicited adverse events (AEs) after the first study intervention administration. An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event. ;Outcome measure 7 - Percentage of adult participants 18–50 years of age with unsolicited adverse events (AEs) after the second study intervention administration. An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any ‘soli | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome measure 50 - Anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in adult participants 18–50 years of age Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG GMCs are assessed. ;Outcome measure 51 - Anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in child participants 24–59 months of age Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG GMCs are assessed. ;Outcome measure 52 - Anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in infant participants 9 months of age Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG GMCs are assessed. ;Outcome measure 53 - Anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in infant participants 6 weeks of age Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG GMCs are assessed. ;Outcome measure 54 - Percentage of adult participants 18–50 years of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise in anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) antibody concentration Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgGantibody concentrations are assessed. ;Outcome measure 55 - Percentage of child participants 24–59 months of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise in anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) antibody concentration Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG antibody concentrations are assessed. ;Outcome measure 56 - Percentage of infant participants 9 months of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise | — |
Countries
Ghana
Contacts
Public ContactMichael Owusu Ansah
Study doctor for KNUST
Outcome results
None listed