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Safety and Immunogenicity of a Novel Conjugate Vaccine Against Salmonella Typhi and Salmonella Paratyphi A in Healthy Adults

Primary Purpose

Typhoid Fever

Status
Recruiting
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
TYP04A Low Dose without adjuvant investigational vaccine
TYP04B Full Dose without adjuvant investigational vaccine
TYP03A Low Dose adjuvanted investigational vaccine
TYP03B Full Dose adjuvanted investigational vaccine
Sanofi Pasteur's Typhoid Vi polysaccharide vaccine
GSK's Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Typhoid Fever focused on measuring Salmonella Typhi, Salmonella Paratyphi A, Typhoid fever, Paratyphoid fever, Enteric fever, Conjugate vaccine, First-time-in-human

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 (e.g., completion of the diary cards, return for follow-up visits). Written informed consent obtained from the participant prior to performance of any study specific procedure. Healthy participants as established by medical history, clinical examination, and screening laboratory investigations. Participant satisfying screening requirements. Participant seronegative for human immunodeficiency virus, hepatitis B, and hepatitis C at Screening. A male or female participant 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. Exclusion Criteria: Medical conditions Progressive, unstable or uncontrolled clinical conditions. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. Hypersensitivity, including allergy, to medicinal products or medical equipment whose use is foreseen in this study. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). Any behavioural 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. Acute* or chronic illness, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests. *Participants with a minor illness (such as mild diarrhoea or mild upper respiratory infection) without fever may be enrolled at the discretion of the Investigator. Any clinically significant* haematological and/or biochemical laboratory abnormality. *The Investigator should use his/her clinical judgement to decide which abnormalities are clinically significant. Confirmed positive COVID-19 test during the period starting 14 days before the first administration of study vaccines (Day -14 to Day 1). Any other clinical condition that, in the opinion of the Investigator, might pose additional risk to the participant due to participation in the study. Confirmed or suspected autoimmune diseases (e.g., vitiligo, autoimmune thyroiditis). Prior/Concomitant therapy Previous administration of any type of Typhoid vaccine (Ty21a, Vi-PS, or Typhoid conjugate vaccine). Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study interventions during the period starting 30 days before the first administration of study vaccines (Day -30 to Day 1), or 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 (-21 days in the case of live vaccines) and ending 28 days after the last dose of study intervention administration*, with the exception of flu and COVID-19 vaccines, administered during the period starting at 7 days before and 7 days after each dose (14 days before and 14 days after in case of live vaccines). *In case emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organised by public health authorities outside the routine immunisation programme, 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 (e.g., infliximab). Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose of study intervention 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. 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 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 vaccine/product (drug/invasive medical device). Other exclusions History of travel to countries of Asia that are considered endemic for enteric fever in the last 3 years. Pregnant or lactating female. Female participants planning to become pregnant or planning to discontinue contraceptive precautions. History of or current chronic alcohol consumption and/or drug abuse. Any study personnel or immediate dependents, family, or household member.

Sites / Locations

  • GSK Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Experimental

Active Comparator

Arm Label

Step 1a low dose without adjuvant Group

Step 1a control Group

Step 1b low dose with adjuvant Group

Step 1b control Group

Step 2 full dose without adjuvant Group

Step 2 full dose with adjuvant Group

Step 2 control Group

Arm Description

Participants 18 to 50 years of age randomized to receive 2 doses of TYP04A Low Dose without adjuvant investigational vaccine, administered at Day 1 and Day 169.

Participants 18 to 50 years of age randomized to receive 1 dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine at Day 1 and 1 dose of GSK's Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine at Day 169.

Participants 18 to 50 years of age randomized to receive 2 doses of TYP03A Low Dose adjuvanted investigational vaccine, administered at Day 1 and Day 169.

Participants 18 to 50 years of age randomized to receive 1 dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine at Day 1 and 1 dose of GSK's Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine at Day 169.

Participants 18 to 50 years of age randomized to receive 2 doses of TYP04B Full Dose without adjuvant investigational vaccine, administered at Day 1 and Day 169.

Participants 18 to 50 years of age randomized to receive 2 doses of TYP03B Full Dose adjuvanted investigational vaccine, administered at Day 1 and Day 169.

Participants 18 to 50 years of age randomized to receive 1 dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine at Day 1 and 1 dose of GSK's Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine at Day 169.

Outcomes

Primary Outcome Measures

Percentage of participants with solicited administration-site events after the first vaccination
The solicited administration site events are pain, redness, and swelling.
Percentage of participants with solicited administration-site events after the second vaccination
The solicited administration site events are pain, redness, and swelling.
Percentage of participants with solicited systemic events after the first vaccination
The solicited systemic events are fever, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). 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.
Percentage of participants with solicited systemic events after the second vaccination
The solicited systemic events are fever, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). 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.
Percentage of participants with unsolicited adverse events after the first vaccination
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.
Percentage of participants with unsolicited adverse events after the second vaccination
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.
Percentage of participants with any serious adverse event (SAE)
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, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
Percentage of participants with AEs/SAEs leading to withdrawal from the study or withholding further study intervention administration
Any AEs including SAEs that lead to discontinuation of the study intervention and/or the study are considered under this outcome measure. 'Discontinuation' of study intervention refers to any participant who has not received all planned doses of study intervention. A participant who discontinued study intervention may continue other study procedures (e.g., safety or immunogenicity), planned in the study protocol at the discretion of the Investigator. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact.
Percentage of participants with deviations from normal or baseline values of haematological, renal, and hepatic panel test results at Day 8
Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, aspartate aminotransferase, alanine aminotransferase, and blood urea.
Percentage of participants with deviations from normal or baseline values of haematological, renal, and hepatic panel test results at Day 176
Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, aspartate aminotransferase, alanine aminotransferase, and blood urea.

Secondary Outcome Measures

Percentage of participants with any serious adverse event (SAE)
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, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
Percentage 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. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact.
Anti-Vi antigen Immunoglobulin G (IgG) antibody concentrations
Anti-Vi antigen IgG antibody concentrations are expressed as geometric mean concentrations (GMCs), as measured by Enzyme-Linked Immunosorbent Assay (ELISA).
Anti-O:2 Immunoglobulin G (IgG) antibody concentrations
Anti-O:2 IgG antibody concentrations are expressed as geometric mean concentrations (GMCs), as measured by Enzyme-Linked Immunosorbent Assay (ELISA).
Percentage of participants achieving anti-Vi antigen IgG antibody concentrations equal to or above (≥) 4.3 micrograms per milliliter (µg/mL)
Percentage of participants achieving anti-Vi antigen IgG antibody concentrations ≥ 2.0 µg/mL
Percentage of participants achieving at least 4-fold increase in anti-O:2 IgG antibody concentrations

Full Information

First Posted
November 4, 2022
Last Updated
May 3, 2023
Sponsor
GlaxoSmithKline
Collaborators
Biological E. Limited
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1. Study Identification

Unique Protocol Identification Number
NCT05613205
Brief Title
Safety and Immunogenicity of a Novel Conjugate Vaccine Against Salmonella Typhi and Salmonella Paratyphi A in Healthy Adults
Official Title
A Phase 1, Observer-blind, Randomised, Controlled, Single-centre Study to Evaluate the Safety, Reactogenicity, and Immune Responses to an Adjuvanted and Non-adjuvanted Conjugate Vaccine Against Salmonella Typhi and Salmonella Paratyphi A in Healthy Adults 18 to 50 Years of Age in Europe
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
February 7, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
Collaborators
Biological E. Limited

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
No

5. Study Description

Brief Summary
A bivalent Typhoid and Paratyphoid A conjugate investigational vaccine aimed to prevent both typhoid and paratyphoid enteric fever in infants and older age groups has been developed by GlaxoSmithKline (GSK). The purpose of this first-time-in-human study is to evaluate the safety and immunogenicity profile of a low and a full dose of the investigational vaccine, formulated with or without adjuvant, administered in 2 doses, 24 weeks apart, in healthy adults 18 to 50 years of age in Europe.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Typhoid Fever
Keywords
Salmonella Typhi, Salmonella Paratyphi A, Typhoid fever, Paratyphoid fever, Enteric fever, Conjugate vaccine, First-time-in-human

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Data will be collected in an observer-blind (Day 1 to Day 197) and in a partially observer-blind (Day 197 to Day 337) manner.
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Step 1a low dose without adjuvant Group
Arm Type
Experimental
Arm Description
Participants 18 to 50 years of age randomized to receive 2 doses of TYP04A Low Dose without adjuvant investigational vaccine, administered at Day 1 and Day 169.
Arm Title
Step 1a control Group
Arm Type
Active Comparator
Arm Description
Participants 18 to 50 years of age randomized to receive 1 dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine at Day 1 and 1 dose of GSK's Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine at Day 169.
Arm Title
Step 1b low dose with adjuvant Group
Arm Type
Experimental
Arm Description
Participants 18 to 50 years of age randomized to receive 2 doses of TYP03A Low Dose adjuvanted investigational vaccine, administered at Day 1 and Day 169.
Arm Title
Step 1b control Group
Arm Type
Active Comparator
Arm Description
Participants 18 to 50 years of age randomized to receive 1 dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine at Day 1 and 1 dose of GSK's Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine at Day 169.
Arm Title
Step 2 full dose without adjuvant Group
Arm Type
Experimental
Arm Description
Participants 18 to 50 years of age randomized to receive 2 doses of TYP04B Full Dose without adjuvant investigational vaccine, administered at Day 1 and Day 169.
Arm Title
Step 2 full dose with adjuvant Group
Arm Type
Experimental
Arm Description
Participants 18 to 50 years of age randomized to receive 2 doses of TYP03B Full Dose adjuvanted investigational vaccine, administered at Day 1 and Day 169.
Arm Title
Step 2 control Group
Arm Type
Active Comparator
Arm Description
Participants 18 to 50 years of age randomized to receive 1 dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine at Day 1 and 1 dose of GSK's Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine at Day 169.
Intervention Type
Biological
Intervention Name(s)
TYP04A Low Dose without adjuvant investigational vaccine
Other Intervention Name(s)
Typhoid and Paratyphoid A conjugate low dose without adjuvant vaccine
Intervention Description
2 doses of TYP04A Low Dose without adjuvant investigational vaccine administered intramuscularly, at Day 1 and Day 169, to participants in the Step 1a low dose without adjuvant Group.
Intervention Type
Biological
Intervention Name(s)
TYP04B Full Dose without adjuvant investigational vaccine
Other Intervention Name(s)
Typhoid and Paratyphoid A conjugate full dose without adjuvant vaccine
Intervention Description
2 doses of TYP04B Full Dose without adjuvant investigational vaccine administered intramuscularly, at Day 1 and Day 169, to participants in the Step 2 full dose without adjuvant Group.
Intervention Type
Biological
Intervention Name(s)
TYP03A Low Dose adjuvanted investigational vaccine
Other Intervention Name(s)
Adjuvanted Typhoid and Paratyphoid A conjugate low dose vaccine
Intervention Description
2 doses of TYP03A Low Dose adjuvanted investigational vaccine administered intramuscularly, at Day 1 and Day 169, to participants in the Step 1b low dose with adjuvant Group.
Intervention Type
Biological
Intervention Name(s)
TYP03B Full Dose adjuvanted investigational vaccine
Other Intervention Name(s)
Adjuvanted Typhoid and Paratyphoid A conjugate full dose vaccine
Intervention Description
2 doses of TYP03B Full Dose adjuvanted investigational vaccine administered intramuscularly, at Day 1 and Day 169, to participants in the Step 2 full dose with adjuvant Group.
Intervention Type
Biological
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 1, to participants in the Step 1a control, Step 1b control, and Step 2 control groups.
Intervention Type
Biological
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 169, to participants in the Step 1a control, Step 1b control, and Step 2 control groups.
Primary Outcome Measure Information:
Title
Percentage of participants with solicited administration-site events after the first vaccination
Description
The solicited administration site events are pain, redness, and swelling.
Time Frame
During 7 days after the first vaccination occurring at Day 1
Title
Percentage of participants with solicited administration-site events after the second vaccination
Description
The solicited administration site events are pain, redness, and swelling.
Time Frame
During 7 days after the second vaccination occurring at Day 169
Title
Percentage of participants with solicited systemic events after the first vaccination
Description
The solicited systemic events are fever, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). 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 vaccination occurring at Day 1
Title
Percentage of participants with solicited systemic events after the second vaccination
Description
The solicited systemic events are fever, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). 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 second vaccination occurring at Day 169
Title
Percentage of participants with unsolicited adverse events after the first vaccination
Description
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.
Time Frame
During 28 days after the first vaccination occurring at Day 1
Title
Percentage of participants with unsolicited adverse events after the second vaccination
Description
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.
Time Frame
During 28 days after the second vaccination occurring at Day 169
Title
Percentage of participants with any serious adverse event (SAE)
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, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
Time Frame
From Day 1 to Day 197
Title
Percentage of participants with AEs/SAEs leading to withdrawal from the study or withholding further study intervention administration
Description
Any AEs including SAEs that lead to discontinuation of the study intervention and/or the study are considered under this outcome measure. 'Discontinuation' of study intervention refers to any participant who has not received all planned doses of study intervention. A participant who discontinued study intervention may continue other study procedures (e.g., safety or immunogenicity), planned in the study protocol at the discretion of the Investigator. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact.
Time Frame
From Day 1 to Day 197
Title
Percentage of participants with deviations from normal or baseline values of haematological, renal, and hepatic panel test results at Day 8
Description
Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, aspartate aminotransferase, alanine aminotransferase, and blood urea.
Time Frame
At Day 8 (7 days after the first vaccination)
Title
Percentage of participants with deviations from normal or baseline values of haematological, renal, and hepatic panel test results at Day 176
Description
Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, aspartate aminotransferase, alanine aminotransferase, and blood urea.
Time Frame
At Day 176 (7 days after the second vaccination)
Secondary Outcome Measure Information:
Title
Percentage of participants with any serious adverse event (SAE)
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, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
Time Frame
From Day 197 to Day 337
Title
Percentage 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. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact.
Time Frame
From Day 197 to Day 337
Title
Anti-Vi antigen Immunoglobulin G (IgG) antibody concentrations
Description
Anti-Vi antigen IgG antibody concentrations are expressed as geometric mean concentrations (GMCs), as measured by Enzyme-Linked Immunosorbent Assay (ELISA).
Time Frame
At Day 1 (before the first vaccination), Day 29 (28 days after the first vaccination), Day 169 (before the second vaccination), Day 176 (7 days after the second vaccination), and Day 197 (28 days after the second vaccination)
Title
Anti-O:2 Immunoglobulin G (IgG) antibody concentrations
Description
Anti-O:2 IgG antibody concentrations are expressed as geometric mean concentrations (GMCs), as measured by Enzyme-Linked Immunosorbent Assay (ELISA).
Time Frame
At Day 1 (before the first vaccination), Day 29 (28 days after the first vaccination), Day 169 (before the second vaccination), Day 176 (7 days after the second vaccination), and Day 197 (28 days after the second vaccination)
Title
Percentage of participants achieving anti-Vi antigen IgG antibody concentrations equal to or above (≥) 4.3 micrograms per milliliter (µg/mL)
Time Frame
At Day 1 (before the first vaccination), Day 29 (28 days after the first vaccination), Day 169 (before the second vaccination), Day 176 (7 days after the second vaccination), and Day 197 (28 days after the second vaccination)
Title
Percentage of participants achieving anti-Vi antigen IgG antibody concentrations ≥ 2.0 µg/mL
Time Frame
At Day 1 (before the first vaccination), Day 29 (28 days after the first vaccination), Day 169 (before the second vaccination), Day 176 (7 days after the second vaccination), and Day 197 (28 days after the second vaccination)
Title
Percentage of participants achieving at least 4-fold increase in anti-O:2 IgG antibody concentrations
Time Frame
At Day 29 (28 days after the first vaccination), Day 169 (before the second vaccination), Day 176 (7 days after the second vaccination), and Day 197 (28 days after the second vaccination) compared to Day 1 (first vaccination baseline)

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 (e.g., completion of the diary cards, return for follow-up visits). Written informed consent obtained from the participant prior to performance of any study specific procedure. Healthy participants as established by medical history, clinical examination, and screening laboratory investigations. Participant satisfying screening requirements. Participant seronegative for human immunodeficiency virus, hepatitis B, and hepatitis C at Screening. A male or female participant 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. Exclusion Criteria: Medical conditions Progressive, unstable or uncontrolled clinical conditions. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. Hypersensitivity, including allergy, to medicinal products or medical equipment whose use is foreseen in this study. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). Any behavioural 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. Acute* or chronic illness, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests. *Participants with a minor illness (such as mild diarrhoea or mild upper respiratory infection) without fever may be enrolled at the discretion of the Investigator. Any clinically significant* haematological and/or biochemical laboratory abnormality. *The Investigator should use his/her clinical judgement to decide which abnormalities are clinically significant. Confirmed positive COVID-19 test during the period starting 14 days before the first administration of study vaccines (Day -14 to Day 1). Any other clinical condition that, in the opinion of the Investigator, might pose additional risk to the participant due to participation in the study. Confirmed or suspected autoimmune diseases (e.g., vitiligo, autoimmune thyroiditis). Prior/Concomitant therapy Previous administration of any type of Typhoid vaccine (Ty21a, Vi-PS, or Typhoid conjugate vaccine). Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study interventions during the period starting 30 days before the first administration of study vaccines (Day -30 to Day 1), or 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 (-21 days in the case of live vaccines) and ending 28 days after the last dose of study intervention administration*, with the exception of flu and COVID-19 vaccines, administered during the period starting at 7 days before and 7 days after each dose (14 days before and 14 days after in case of live vaccines). *In case emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organised by public health authorities outside the routine immunisation programme, 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 (e.g., infliximab). Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose of study intervention 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. 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 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 vaccine/product (drug/invasive medical device). Other exclusions History of travel to countries of Asia that are considered endemic for enteric fever in the last 3 years. Pregnant or lactating female. Female participants planning to become pregnant or planning to discontinue contraceptive precautions. History of or current chronic alcohol consumption and/or drug abuse. Any study personnel or immediate dependents, family, or household member.
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
Wilrijk
ZIP/Postal Code
2610
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
Ilse De Coster

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.

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Safety and Immunogenicity of a Novel Conjugate Vaccine Against Salmonella Typhi and Salmonella Paratyphi A in Healthy Adults

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