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A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella and Typhoid Fever

Primary Purpose

Salmonella Infections

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Invasive nontyphoidal Salmonella-typhoid conjugate vaccine (iNTS-TCV) low dose
Invasive nontyphoidal Salmonella-generalized modules for membrane antigens vaccine (iNTS-GMMA) low dose
Typhoid conjugate vaccine (TCV) low dose
Invasive nontyphoidal Salmonella-typhoid conjugate vaccine (iNTS-TCV) full dose
Invasive nontyphoidal Salmonella-generalized modules for membrane antigens vaccine (iNTS-GMMA) full dose
Typhoid conjugate vaccine (TCV) full dose
GSK's Meningococcal A, C, Y and W-135 conjugate vaccine
GSK's Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine
Sanofi Pasteur's Typhoid Vi polysaccharide vaccine
Placebo
Saline
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Salmonella Infections

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria

  • Participants, who, in the opinion of the Investigator, can and will comply with the requirements of the protocol.
  • Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study-specific procedure.
  • Healthy participants as established by medical history, clinical examination, and laboratory assessment.
  • Participant satisfying screening requirements.
  • 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 nonchildbearing potential may be enrolled in the study. Nonchildbearing 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 trial 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.
  • Blood sample for simultaneous follicle-stimulating hormone (FSH) and estradiol levels may be collected at the discretion of the Investigator to confirm non-reproductive potential according to local laboratory reference range.
  • Genetic testing for HLA-B27 will be performed at Screening and only participants with a negative result will be allowed to participate in the study*.

    • Only for Stage 1.
  • For Malawi (Stage 2), the participant lives in Blantyre and has agreed to remain in Blantyre for the study duration.

Exclusion criteria Medical Conditions

  • Known exposure to S. Typhi and nontyphoidal Salmonella confirmed by blood culture during the period starting 3 years prior to first study intervention administration confirmed using past medical history.
  • History of any reaction or hypersensitivity associated with any component of the study interventions.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Recurrent history or uncontrolled neurological disorders or seizures.
  • Any clinically significant* hematological and/or biochemical laboratory abnormality.

    • The Investigator should use his/her clinical judgment to decide which abnormalities are clinically significant from the panel of tests in the list of safety assays.
  • Clinical conditions representing a contraindication to IM injections and/or 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.
  • Confirmed positive COVID-19 polymerase chain reaction or lateral flow test during the period starting 28 days before the first administration of study vaccines (Day -28 to Day 1).
  • Acute or chronic illness which may be severe enough to preclude participation.
  • Any other clinical condition that, in the opinion of the Investigator, might pose additional risk to the participant due to participation in the study.
  • All medical conditions will be assessed by the Investigator who may use his/her discretion to decide if the participant meets the exclusion criteria.

Prior/Concomitant Therapy

  • History of receiving any typhoid vaccine (Ty21a, Vi capsular polysaccharide, or TCV) in the participant's life.
  • 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 (Days -30 to 1) before the first dose of study interventions, or their planned use during the study period.
  • A vaccine not foreseen by the study protocol administered during the period starting at 14 days before the first dose and ending 28 days after the last dose of study interventions administration*, with the exception of flu vaccines or COVID-19 vaccine.

    • In case emergency mass vaccination for an unforeseen public health threat (eg, a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.

When regulations allow, the recommended time intervals for administration of these vaccines are at least 7 days before or 7 days after (at least 14 days before or 14 days after in case of live vaccines) each dose of study intervention administration.

  • Administration of long-acting immune-modifying drugs at any time during the study period (eg, infliximab).
  • Administration of Ig and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose of study interventions 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). For corticosteroids, this will mean prednisone equivalent ≥20 mg/day for adult participants. Inhaled and topical steroids are allowed.

Prior/Concurrent Clinical Study Experience

- Concurrently participating in another clinical trial, 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 and drug).

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. Chronic alcohol consumption is defined as one or more of the following:
  • A prolonged period of frequent and heavy alcohol use
  • The inability to control drinking once it has begun
  • Physical dependence manifested by withdrawal symptoms when the individual stops using alcohol
  • Tolerance or the need to use increasing amounts of alcohol to achieve the same effects
  • A variety of social and/or legal problems arising from alcohol use.
  • Any study personnel or their immediate dependents, family, or household members.

Sites / Locations

  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Active Comparator

Placebo Comparator

Experimental

Active Comparator

Placebo Comparator

Experimental

Active Comparator

Active Comparator

Arm Label

iNTS-TCV low dose Group

iNTS-GMMA and TCV low doses Group

Placebo _Step 1 Group

iNTS-TCV full dose_1 Group

iNTS-GMMA and TCV full doses_1 Group

Placebo_Step 2 Group

iNTS-TCV full dose_2 Group

iNTS-GMMA and TCV full doses_2 Group

Control_Stage 2 Group

Arm Description

Participants 18 to 50 years of age in Stage 1 (Europe) randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution, administered in different arms, at Days 1, 57, and 169.

Participants 18 to 50 years of age in Stage 1 (Europe) randomized to receive 3 doses of iNTS-GMMA low dose vaccine and 3 doses of TCV low dose vaccine, administered in different arms, at Days 1, 57, and 169.

Participants 18 to 50 years of age in Stage 1 (Europe) randomized to receive 3 doses of placebo and 3 doses of saline solution, administered in different arms, at Days 1, 57, and 169.

Participants 18 to 50 years of age in Stage 1 (Europe) randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution, administered in different arms, at Days 1, 57, and 169.

Participants 18 to 50 years of age in Stage 1 (Europe) randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine, administered in different arms, at Days 1, 57, and 169.

Participants 18 to 50 years of age in Stage 1 (Europe) randomized to receive 3 doses of placebo and 3 doses of saline solution, administered in different arms, at Days 1, 57, and 169.

Participants 18 to 50 years of age in Stage 2 (Africa) randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution, administered in different arms, at Days 1, 57, and 169.

Participants 18 to 50 years of age in Stage 2 (Africa) randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine, administered in different arms, at Days 1, 57, and 169.

Participants 18 to 50 years of age in Stage 2 (Africa) randomized to receive one dose of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine administered at Day 1, one dose of GSK's Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine administered at Day 57, one dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine administered at Day 169, and 3 doses of saline solution administered at Days 1, 57 and 169.

Outcomes

Primary Outcome Measures

Number of participants in Europe/Stage 1 with solicited administration site events after the first study intervention administration
The solicited administration site events are pain, redness, and swelling.
Number of participants in Europe/Stage 1 with solicited administration site events after the second study intervention administration
The solicited administration site events are pain, redness, and swelling.
Number of participants in Europe/Stage 1 with solicited administration site events after the third study intervention administration
The solicited administration site events are pain, redness, and swelling.
Number of participants in Europe/Stage 1 with solicited systemic events after the first study intervention administration
The solicited systemic events are fever, headache, myalgia, arthralgia, and fatigue. Fever is defined as body temperature equal to or above (≥) 38.0 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F). The preferred location for measuring temperature is the axilla.
Number of participants in Europe/Stage 1 with solicited systemic events after the second study intervention administration
The solicited systemic events are fever, headache, myalgia, arthralgia, and fatigue. Fever is defined as body temperature ≥ 38.0 °C/100.4 °F. The preferred location for measuring temperature is the axilla.
Number of participants in Europe/Stage 1 with solicited systemic events after the third study intervention administration
The solicited systemic events are fever, headache, myalgia, arthralgia, and fatigue. Fever is defined as body temperature ≥ 38.0 °C/100.4 °F. The preferred location for measuring temperature is the axilla.
Number of participants in Europe/Stage 1 with unsolicited adverse events (AEs) after the first study intervention administration
An unsolicited AE is an 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 is reported as an unsolicited AE.
Number of participants in Europe/Stage 1 with unsolicited adverse events (AEs) after the second study intervention administration
An unsolicited AE is an 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 is reported as an unsolicited AE.
Number of participants in Europe/Stage 1 with unsolicited adverse events (AEs) after the third study intervention administration
An unsolicited AE is an 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 is reported as an unsolicited AE.
Number of participants in Europe/Stage 1 with serious adverse events (SAEs)
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, represents a congenital anomaly/birth defect in the offspring of a study participant or abnormal pregnancy outcomes.
Number of participants in Europe/Stage 1 with AEs/SAEs leading to withdrawal from the study and/or withholding doses of study intervention
Any AEs including SAEs that lead to discontinuation of study intervention and/or the study are considered under this outcome measure.
Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 8
Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 64
Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 176
Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 29
Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 85
Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 197
Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
Number of participants in Africa/Stage 2 with solicited administration site events after the first study intervention administration
The solicited administration site events are pain, redness, and swelling.
Number of participants in Africa/Stage 2 with solicited administration site events after the second study intervention administration
The solicited administration site events are pain, redness, and swelling.
Number of participants in Africa/Stage 2 with solicited administration site events after the third study intervention administration
The solicited administration site events are pain, redness, and swelling.
Number of participants in Africa/Stage 2 with solicited systemic events after the first study intervention administration
The solicited systemic events are fever, headache, myalgia, arthralgia, and fatigue. Fever is defined as body temperature ≥ 38.0 °C/100.4 °F. The preferred location for measuring temperature is the axilla.
Number of participants in Africa/Stage 2 with solicited systemic events after the second study intervention administration
The solicited systemic events are fever, headache, myalgia, arthralgia, and fatigue. Fever is defined as body temperature ≥ 38.0 °C/100.4 °F. The preferred location for measuring temperature is the axilla.
Number of participants in Africa/Stage 2 with solicited systemic events after the third study intervention administration
The solicited systemic events are fever, headache, myalgia, arthralgia, and fatigue. Fever is defined as body temperature ≥ 38.0 °C/100.4 °F. The preferred location for measuring temperature is the axilla.
Number of participants in Africa/Stage 2 with unsolicited adverse events (AEs) after the first study intervention administration
An unsolicited AE is an 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 is reported as an unsolicited AE.
Number of participants in Africa/Stage 2 with unsolicited adverse events (AEs) after the second study intervention administration
An unsolicited AE is an 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 is reported as an unsolicited AE.
Number of participants in Africa/Stage 2 with unsolicited adverse events (AEs) after the third study intervention administration
Any unsolicited AE is an 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 is reported as an unsolicited AE.
Number of participants in Africa/Stage 2 with serious adverse events (SAEs)
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, represents a congenital anomaly/birth defect in the offspring of a study participant or abnormal pregnancy outcomes.
Number of participants in Africa/Stage 2 with AEs/SAEs leading to withdrawal from the study and/or withholding doses of study intervention
Any AEs including SAEs that lead to discontinuation of study intervention and/or the study are considered under this outcome measure.
Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 8
Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 64
Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 176
Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 29
Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 85
Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 197
Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.

Secondary Outcome Measures

Number of participants with serious adverse events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is lifethreatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, represents a congenital anomaly/birth defect in the offspring of a study participant or abnormal pregnancy outcomes.
Number of participants with AEs/SAEs leading to withdrawal from the study
Any AEs including SAEs that lead to discontinuation of the study are considered under this outcome measure.
Anti-serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in participants in Europe/Stage 1, and between-group ratios
Anti-S. Typhi Vi antigen (Ag) total IgG, Anti-S. Typhimurium O Ag total IgG, Anti-S. Enteritidis O Ag total IgG GMCs and between-group ratios are assessed.
Anti-serotype specific immunoglobulin G (IgG) within-participant geometric mean ratios (GMRs) in participants in Europe/Stage 1
Anti-S. Typhi Vi antigen (Ag) total IgG, Anti-S. Typhimurium O Ag total IgG, Anti-S. Enteritidis O Ag total IgG within-participant GMRs are assessed.
Number of participants in Europe/Stage 1 achieving, for each antigen (Ag), at least a 4-fold rise in anti-serotype specific immunoglobulin G (IgG) antibody concentration
Anti-S. Typhi Vi Ag total IgG, Anti-S. Typhimurium O Ag total IgG, Anti-S. Enteritidis O Ag total IgG antibody concentrations are assessed.
Number of participants in Europe/Stage 1 with Anti-S. typhi Vi Ag IgG antibody concentrations equivalent to ≥ 4.3 micrograms per milliliter (µg/mL)
Anti-serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in participants in Africa/Stage 2, and between-group ratios
Anti-S. Typhi Vi Ag total IgG, Anti-S. Typhimurium O Ag total IgG, Anti-S. Enteritidis O Ag total IgG GMCs and between-group ratios are assessed.
Anti-serotype specific immunoglobulin G (IgG) within-participant geometric mean ratios (GMRs) in participants in Africa/Stage 2
Anti-S. Typhi Vi Ag total IgG, Anti-S. Typhimurium O Ag total IgG, Anti-S. Enteritidis O Ag total IgG within-participant GMRs are assessed.
Number of participants in Africa/Stage 2 achieving, for each antigen (Ag), at least a 4-fold rise in anti-serotype specific immunoglobulin G (IgG) antibody concentration
Anti-S. Typhi Vi Ag total IgG, Anti-S. Typhimurium O Ag total IgG, Anti-S. Enteritidis O Ag total IgG antibody concentrations are assessed.
Number of participants in Africa/Stage 2 with Anti-S. Typhi Vi antigen (Ag) immunoglobulin G (IgG) antibody concentrations equivalent to ≥ 4.3 micrograms per milliliter (µg/mL)

Full Information

First Posted
July 27, 2022
Last Updated
September 27, 2023
Sponsor
GlaxoSmithKline
Collaborators
Biomedical Advanced Research and Development Authority, Wellcome Trust, Global Antimicrobial Resistance Innovation Fund-(GAMRIF), Bill and Melinda Gates Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05480800
Brief Title
A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella and Typhoid Fever
Official Title
A Phase 1/2a, Observer-blind, Randomized, Controlled, Two-stage, Multi-country Study to Evaluate the Safety, Reactogenicity, and Immune Response of the Trivalent Vaccine Against Invasive Nontyphoidal Salmonella (iNTS) and Typhoid Fever in Healthy European and African Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2022 (Actual)
Primary Completion Date
October 23, 2024 (Anticipated)
Study Completion Date
November 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
Collaborators
Biomedical Advanced Research and Development Authority, Wellcome Trust, Global Antimicrobial Resistance Innovation Fund-(GAMRIF), Bill and Melinda Gates Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess 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) candidate vaccine to be administered for the first time in humans. The study intervention will be evaluated in European adults in Stage 1 (a 2-step staggered design) followed by African adults in Stage 2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Salmonella Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Data will be collected in an observer-blind manner.
Allocation
Randomized
Enrollment
155 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iNTS-TCV low dose Group
Arm Type
Experimental
Arm Description
Participants 18 to 50 years of age in Stage 1 (Europe) randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution, administered in different arms, at Days 1, 57, and 169.
Arm Title
iNTS-GMMA and TCV low doses Group
Arm Type
Active Comparator
Arm Description
Participants 18 to 50 years of age in Stage 1 (Europe) randomized to receive 3 doses of iNTS-GMMA low dose vaccine and 3 doses of TCV low dose vaccine, administered in different arms, at Days 1, 57, and 169.
Arm Title
Placebo _Step 1 Group
Arm Type
Placebo Comparator
Arm Description
Participants 18 to 50 years of age in Stage 1 (Europe) randomized to receive 3 doses of placebo and 3 doses of saline solution, administered in different arms, at Days 1, 57, and 169.
Arm Title
iNTS-TCV full dose_1 Group
Arm Type
Experimental
Arm Description
Participants 18 to 50 years of age in Stage 1 (Europe) randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution, administered in different arms, at Days 1, 57, and 169.
Arm Title
iNTS-GMMA and TCV full doses_1 Group
Arm Type
Active Comparator
Arm Description
Participants 18 to 50 years of age in Stage 1 (Europe) randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine, administered in different arms, at Days 1, 57, and 169.
Arm Title
Placebo_Step 2 Group
Arm Type
Placebo Comparator
Arm Description
Participants 18 to 50 years of age in Stage 1 (Europe) randomized to receive 3 doses of placebo and 3 doses of saline solution, administered in different arms, at Days 1, 57, and 169.
Arm Title
iNTS-TCV full dose_2 Group
Arm Type
Experimental
Arm Description
Participants 18 to 50 years of age in Stage 2 (Africa) randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution, administered in different arms, at Days 1, 57, and 169.
Arm Title
iNTS-GMMA and TCV full doses_2 Group
Arm Type
Active Comparator
Arm Description
Participants 18 to 50 years of age in Stage 2 (Africa) randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine, administered in different arms, at Days 1, 57, and 169.
Arm Title
Control_Stage 2 Group
Arm Type
Active Comparator
Arm Description
Participants 18 to 50 years of age in Stage 2 (Africa) randomized to receive one dose of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine administered at Day 1, one dose of GSK's Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine administered at Day 57, one dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine administered at Day 169, and 3 doses of saline solution administered at Days 1, 57 and 169.
Intervention Type
Biological
Intervention Name(s)
Invasive nontyphoidal Salmonella-typhoid conjugate vaccine (iNTS-TCV) low dose
Intervention Description
3 doses of iNTS-TCV low dose vaccine administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-TCV low dose Group in Stage 1 (Europe).
Intervention Type
Biological
Intervention Name(s)
Invasive nontyphoidal Salmonella-generalized modules for membrane antigens vaccine (iNTS-GMMA) low dose
Intervention Description
3 doses of iNTS-GMMA low dose vaccine administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-GMMA and TCV low doses Group in Stage 1 (Europe).
Intervention Type
Biological
Intervention Name(s)
Typhoid conjugate vaccine (TCV) low dose
Intervention Description
3 doses of TCV low dose vaccine administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-GMMA and TCV low doses Group in Stage 1 (Europe).
Intervention Type
Biological
Intervention Name(s)
Invasive nontyphoidal Salmonella-typhoid conjugate vaccine (iNTS-TCV) full dose
Intervention Description
3 doses of iNTS-TCV full dose vaccine administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-TCV full dose_1 Group in Stage 1 (Europe) and to participants in iNTS-TCV full dose_2 Group in Stage 2 (Africa).
Intervention Type
Biological
Intervention Name(s)
Invasive nontyphoidal Salmonella-generalized modules for membrane antigens vaccine (iNTS-GMMA) full dose
Intervention Description
3 doses of iNTS-GMMA full dose vaccine administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-GMMA and TCV full doses_1 Group in Stage 1 (Europe) and to participants in the iNTS-GMMA and TCV full doses_2 Group in Stage 2 (Africa).
Intervention Type
Biological
Intervention Name(s)
Typhoid conjugate vaccine (TCV) full dose
Intervention Description
3 doses of TCV full dose vaccine administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-GMMA and TCV full doses_1 Group in Stage 1 (Europe) and to participants in the iNTS-GMMA and TCV full doses_2 Group in Stage 2 (Africa).
Intervention Type
Biological
Intervention Name(s)
GSK's Meningococcal A, C, Y and W-135 conjugate vaccine
Other Intervention Name(s)
MENVEO
Intervention Description
1 dose of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine administered intramuscularly at Day 1 to participants in the Control_Stage 2 Group in Stage 2 (Africa).
Intervention Type
Combination Product
Intervention Name(s)
GSK's Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine
Other Intervention Name(s)
Boostrix
Intervention Description
1 dose of GSK's Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine administered intramuscularly at Day 57 to participants in the Control_Stage 2 Group in Stage 2 (Africa).
Intervention Type
Combination Product
Intervention Name(s)
Sanofi Pasteur's Typhoid Vi polysaccharide vaccine
Other Intervention Name(s)
TYPHIM Vi
Intervention Description
1 dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine administered intramuscularly at Day 169 to participants in the Control_Stage 2 Group in Stage 2 (Africa).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
3 doses of Placebo administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the Placebo_Step 1 and Placebo_Step 2 in Stage 1 (Europe).
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
3 doses of saline solution administered intramuscularly at Day 1, Day 57, and Day 169 to participants in the iNTS-TCV low dose, Placebo_Step 1, iNTS-TCV full dose_1, Placebo_Step 2 groups in Stage 1 (Europe) and to participants in iNTS-TCV full dose_2 and Control_Stage 2 groups in Stage 2 (Africa).
Primary Outcome Measure Information:
Title
Number of participants in Europe/Stage 1 with solicited administration site events after the first study intervention administration
Description
The solicited administration site events are pain, redness, and swelling.
Time Frame
During 7 days after the first study intervention administration occurring at Day 1
Title
Number of participants in Europe/Stage 1 with solicited administration site events after the second study intervention administration
Description
The solicited administration site events are pain, redness, and swelling.
Time Frame
During 7 days after the second study intervention administration occurring at Day 57
Title
Number of participants in Europe/Stage 1 with solicited administration site events after the third study intervention administration
Description
The solicited administration site events are pain, redness, and swelling.
Time Frame
During 7 days after the third study intervention administration occurring at Day 169
Title
Number of participants in Europe/Stage 1 with solicited systemic events after the first study intervention administration
Description
The solicited systemic events are fever, headache, myalgia, arthralgia, and fatigue. Fever is defined as body temperature equal to or above (≥) 38.0 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F). The preferred location for measuring temperature is the axilla.
Time Frame
During 7 days after the first study intervention administration occurring at Day 1
Title
Number of participants in Europe/Stage 1 with solicited systemic events after the second study intervention administration
Description
The solicited systemic events are fever, headache, myalgia, arthralgia, and fatigue. Fever is defined as body temperature ≥ 38.0 °C/100.4 °F. The preferred location for measuring temperature is the axilla.
Time Frame
During 7 days after the second study intervention administration occurring at Day 57
Title
Number of participants in Europe/Stage 1 with solicited systemic events after the third study intervention administration
Description
The solicited systemic events are fever, headache, myalgia, arthralgia, and fatigue. Fever is defined as body temperature ≥ 38.0 °C/100.4 °F. The preferred location for measuring temperature is the axilla.
Time Frame
During 7 days after the third study intervention administration occurring at Day 169
Title
Number of participants in Europe/Stage 1 with unsolicited adverse events (AEs) after the first study intervention administration
Description
An unsolicited AE is an 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 is reported as an unsolicited AE.
Time Frame
During 28 days after the first study intervention administration occurring at Day 1
Title
Number of participants in Europe/Stage 1 with unsolicited adverse events (AEs) after the second study intervention administration
Description
An unsolicited AE is an 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 is reported as an unsolicited AE.
Time Frame
During 28 days after the second study intervention administration occurring at Day 57
Title
Number of participants in Europe/Stage 1 with unsolicited adverse events (AEs) after the third study intervention administration
Description
An unsolicited AE is an 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 is reported as an unsolicited AE.
Time Frame
During 28 days after the third study intervention administration occurring at Day 169
Title
Number of participants in Europe/Stage 1 with serious adverse events (SAEs)
Description
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, represents a congenital anomaly/birth defect in the offspring of a study participant or abnormal pregnancy outcomes.
Time Frame
From first study intervention administration (Day 1) up to 28 days after the third study intervention administration (Day 197)
Title
Number of participants in Europe/Stage 1 with AEs/SAEs leading to withdrawal from the study and/or withholding doses of study intervention
Description
Any AEs including SAEs that lead to discontinuation of study intervention and/or the study are considered under this outcome measure.
Time Frame
From first study intervention administration (Day 1) up to 28 days after the third study intervention administration (Day 197)
Title
Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 8
Description
Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
Time Frame
At Day 8 (7 days after the first study intervention administration)
Title
Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 64
Description
Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
Time Frame
At Day 64 (7 days after the second study intervention administration)
Title
Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 176
Description
Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
Time Frame
At Day 176 (7 days after the third study intervention administration)
Title
Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 29
Description
Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
Time Frame
At Day 29 (28 days after the first study intervention administration)
Title
Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 85
Description
Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
Time Frame
At Day 85 (28 days after the second study intervention administration)
Title
Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 197
Description
Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
Time Frame
At Day 197 (28 days after the third study intervention administration)
Title
Number of participants in Africa/Stage 2 with solicited administration site events after the first study intervention administration
Description
The solicited administration site events are pain, redness, and swelling.
Time Frame
During 7 days after the first study intervention administration occurring at Day 1
Title
Number of participants in Africa/Stage 2 with solicited administration site events after the second study intervention administration
Description
The solicited administration site events are pain, redness, and swelling.
Time Frame
During 7 days after the second study intervention administration occurring at Day 57
Title
Number of participants in Africa/Stage 2 with solicited administration site events after the third study intervention administration
Description
The solicited administration site events are pain, redness, and swelling.
Time Frame
During 7 days after the third study intervention administration occurring at Day 169
Title
Number of participants in Africa/Stage 2 with solicited systemic events after the first study intervention administration
Description
The solicited systemic events are fever, headache, myalgia, arthralgia, and fatigue. Fever is defined as body temperature ≥ 38.0 °C/100.4 °F. The preferred location for measuring temperature is the axilla.
Time Frame
During 7 days after the first study intervention administration occurring at Day 1
Title
Number of participants in Africa/Stage 2 with solicited systemic events after the second study intervention administration
Description
The solicited systemic events are fever, headache, myalgia, arthralgia, and fatigue. Fever is defined as body temperature ≥ 38.0 °C/100.4 °F. The preferred location for measuring temperature is the axilla.
Time Frame
During 7 days after the second study intervention administration occurring at Day 57
Title
Number of participants in Africa/Stage 2 with solicited systemic events after the third study intervention administration
Description
The solicited systemic events are fever, headache, myalgia, arthralgia, and fatigue. Fever is defined as body temperature ≥ 38.0 °C/100.4 °F. The preferred location for measuring temperature is the axilla.
Time Frame
During 7 days after the third study intervention administration occurring at Day 169
Title
Number of participants in Africa/Stage 2 with unsolicited adverse events (AEs) after the first study intervention administration
Description
An unsolicited AE is an 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 is reported as an unsolicited AE.
Time Frame
During 28 days after the first study intervention administration occurring at Day 1
Title
Number of participants in Africa/Stage 2 with unsolicited adverse events (AEs) after the second study intervention administration
Description
An unsolicited AE is an 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 is reported as an unsolicited AE.
Time Frame
During 28 days after the second study intervention administration occurring at Day 57
Title
Number of participants in Africa/Stage 2 with unsolicited adverse events (AEs) after the third study intervention administration
Description
Any unsolicited AE is an 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 is reported as an unsolicited AE.
Time Frame
During 28 days after the third study intervention administration occurring at Day 169
Title
Number of participants in Africa/Stage 2 with serious adverse events (SAEs)
Description
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, represents a congenital anomaly/birth defect in the offspring of a study participant or abnormal pregnancy outcomes.
Time Frame
From first study intervention administration (Day 1) up to 28 days after the third study intervention administration (Day 197)
Title
Number of participants in Africa/Stage 2 with AEs/SAEs leading to withdrawal from the study and/or withholding doses of study intervention
Description
Any AEs including SAEs that lead to discontinuation of study intervention and/or the study are considered under this outcome measure.
Time Frame
From first study intervention administration (Day 1) up to 28 days after the third study intervention (Day 197)
Title
Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 8
Description
Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
Time Frame
At Day 8 (7 days after the first study intervention administration)
Title
Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 64
Description
Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
Time Frame
At Day 64 (7 days after the second study intervention administration)
Title
Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 176
Description
Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
Time Frame
At Day 176 (7 days after the third study intervention administration)
Title
Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 29
Description
Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
Time Frame
At Day 29 (28 days after the first study intervention administration)
Title
Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 85
Description
Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
Time Frame
At Day 85 (28 days after the second study intervention administration)
Title
Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 197
Description
Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine.
Time Frame
At Day 197 (28 days after the third study intervention administration)
Secondary Outcome Measure Information:
Title
Number of participants with serious adverse events (SAEs)
Description
An SAE is defined as any untoward medical occurrence that results in death, is lifethreatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, represents a congenital anomaly/birth defect in the offspring of a study participant or abnormal pregnancy outcomes.
Time Frame
From 28 days after the third study intervention administration (Day 197) up to study end (Day 337)
Title
Number of participants with AEs/SAEs leading to withdrawal from the study
Description
Any AEs including SAEs that lead to discontinuation of the study are considered under this outcome measure.
Time Frame
From 28 days after third study intervention administration (Day 197) up to Day 337
Title
Anti-serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in participants in Europe/Stage 1, and between-group ratios
Description
Anti-S. Typhi Vi antigen (Ag) total IgG, Anti-S. Typhimurium O Ag total IgG, Anti-S. Enteritidis O Ag total IgG GMCs and between-group ratios are assessed.
Time Frame
At Days 1, 57, and 169 (before each study intervention administration) and at Days 29, 85, and 197 (28 days after each study intervention administration)
Title
Anti-serotype specific immunoglobulin G (IgG) within-participant geometric mean ratios (GMRs) in participants in Europe/Stage 1
Description
Anti-S. Typhi Vi antigen (Ag) total IgG, Anti-S. Typhimurium O Ag total IgG, Anti-S. Enteritidis O Ag total IgG within-participant GMRs are assessed.
Time Frame
At 28 days after each study intervention administration compared to each study intervention administration baseline (Day 29 versus Day 1, Day 85 versus Day 57 and Day 197 versus Day 169)
Title
Number of participants in Europe/Stage 1 achieving, for each antigen (Ag), at least a 4-fold rise in anti-serotype specific immunoglobulin G (IgG) antibody concentration
Description
Anti-S. Typhi Vi Ag total IgG, Anti-S. Typhimurium O Ag total IgG, Anti-S. Enteritidis O Ag total IgG antibody concentrations are assessed.
Time Frame
At Days 29, 85, and 197 (28 days after each study intervention administration) compared to Day 1 (first study intervention administration baseline)
Title
Number of participants in Europe/Stage 1 with Anti-S. typhi Vi Ag IgG antibody concentrations equivalent to ≥ 4.3 micrograms per milliliter (µg/mL)
Time Frame
At Days 1, 57 and 169 (before each study intervention administration) and at Days 29, 85 and 197 (28 days after each study intervention administration)
Title
Anti-serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in participants in Africa/Stage 2, and between-group ratios
Description
Anti-S. Typhi Vi Ag total IgG, Anti-S. Typhimurium O Ag total IgG, Anti-S. Enteritidis O Ag total IgG GMCs and between-group ratios are assessed.
Time Frame
At Days 1, 57 and 169 (before each study intervention administration) and at Days 29, 85 and 197 (28 days after each study intervention administration)
Title
Anti-serotype specific immunoglobulin G (IgG) within-participant geometric mean ratios (GMRs) in participants in Africa/Stage 2
Description
Anti-S. Typhi Vi Ag total IgG, Anti-S. Typhimurium O Ag total IgG, Anti-S. Enteritidis O Ag total IgG within-participant GMRs are assessed.
Time Frame
At 28 days after each study intervention administration compared to each study intervention administration baseline (Day 29 versus Day 1, Day 85 versus Day 57 and Day 197 versus Day 169)
Title
Number of participants in Africa/Stage 2 achieving, for each antigen (Ag), at least a 4-fold rise in anti-serotype specific immunoglobulin G (IgG) antibody concentration
Description
Anti-S. Typhi Vi Ag total IgG, Anti-S. Typhimurium O Ag total IgG, Anti-S. Enteritidis O Ag total IgG antibody concentrations are assessed.
Time Frame
At Days 29, 85 and 197 (28 days after each study intervention administration) compared to Day 1 (first study intervention administration baseline)
Title
Number of participants in Africa/Stage 2 with Anti-S. Typhi Vi antigen (Ag) immunoglobulin G (IgG) antibody concentrations equivalent to ≥ 4.3 micrograms per milliliter (µg/mL)
Time Frame
At Days 1, 57 and 169 (before each study intervention administration) and at Days 29, 85 and 197 (28 days after each study intervention administration)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria Participants, who, in the opinion of the Investigator, can and will comply with the requirements of the protocol. Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study-specific procedure. Healthy participants as established by medical history, clinical examination, and laboratory assessment. Participant satisfying screening requirements. 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 nonchildbearing potential may be enrolled in the study. Nonchildbearing 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 trial 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. Blood sample for simultaneous follicle-stimulating hormone (FSH) and estradiol levels may be collected at the discretion of the Investigator to confirm non-reproductive potential according to local laboratory reference range. Genetic testing for HLA-B27 will be performed at Screening and only participants with a negative result will be allowed to participate in the study*. Only for Stage 1. For Malawi (Stage 2), the participant lives in Blantyre and has agreed to remain in Blantyre for the study duration. Exclusion criteria Medical Conditions Known exposure to S. Typhi and nontyphoidal Salmonella confirmed by blood culture during the period starting 3 years prior to first study intervention administration confirmed using past medical history. History of any reaction or hypersensitivity associated with any component of the study interventions. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests. Recurrent history or uncontrolled neurological disorders or seizures. Any clinically significant* hematological and/or biochemical laboratory abnormality. The Investigator should use his/her clinical judgment to decide which abnormalities are clinically significant from the panel of tests in the list of safety assays. Clinical conditions representing a contraindication to IM injections and/or 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. Confirmed positive COVID-19 polymerase chain reaction or lateral flow test during the period starting 28 days before the first administration of study vaccines (Day -28 to Day 1). Acute or chronic illness which may be severe enough to preclude participation. Any other clinical condition that, in the opinion of the Investigator, might pose additional risk to the participant due to participation in the study. All medical conditions will be assessed by the Investigator who may use his/her discretion to decide if the participant meets the exclusion criteria. Prior/Concomitant Therapy History of receiving any typhoid vaccine (Ty21a, Vi capsular polysaccharide, or TCV) in the participant's life. 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 (Days -30 to 1) before the first dose of study interventions, or their planned use during the study period. A vaccine not foreseen by the study protocol administered during the period starting at 14 days before the first dose and ending 28 days after the last dose of study interventions administration*, with the exception of flu vaccines or COVID-19 vaccine. In case emergency mass vaccination for an unforeseen public health threat (eg, a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly. When regulations allow, the recommended time intervals for administration of these vaccines are at least 7 days before or 7 days after (at least 14 days before or 14 days after in case of live vaccines) each dose of study intervention administration. Administration of long-acting immune-modifying drugs at any time during the study period (eg, infliximab). Administration of Ig and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose of study interventions 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). For corticosteroids, this will mean prednisone equivalent ≥20 mg/day for adult participants. Inhaled and topical steroids are allowed. Prior/Concurrent Clinical Study Experience - Concurrently participating in another clinical trial, 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 and drug). 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. Chronic alcohol consumption is defined as one or more of the following: A prolonged period of frequent and heavy alcohol use The inability to control drinking once it has begun Physical dependence manifested by withdrawal symptoms when the individual stops using alcohol Tolerance or the need to use increasing amounts of alcohol to achieve the same effects A variety of social and/or legal problems arising from alcohol use. Any study personnel or their immediate dependents, family, or household members.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name or Official Title & Degree
EU GSK Clinical Trials Call Center
Phone
+44 (0) 20 89904466
Email
GSKClinicalSupportHD@gsk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Kanchanamala Withanage
Facility Name
GSK Investigational Site
City
Blantyre 3
Country
Malawi
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Melita Alison Gordon

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.

Learn more about this trial

A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella and Typhoid Fever

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