A Study on the Safety, Reactogenicity, and Immune Response to the GVGH iNTS-GMMA Vaccine Against Invasive Nontyphoidal Salmonella in Adults, Children, and Infants
A Phase IIa Observer-blind, Randomized, Controlled, Age-de-escalation, Single Center Interventional Study to Evaluate the Safety, Reactogenicity, and Immune Response of the GVGH iNTS Vaccine Against S. Typhimurium and S. Enteritidis, in Adults, Children and Infants, Including Dose-finding in Infants, in Africa
1 other identifier
interventional
516
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety, reactogenicity, and immune response of the GlaxoSmithKline (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-generalized modules for membrane antigens (iNTS-GMMA) candidate vaccine against S. Typhimurium and S. Enteritidis with an age de-escalation and dose escalation approach in African population, starting with adults (18-50 years of age), then on children (24-59 months of age) and finally to infants (9 months and 6 weeks of age). Infants are the target for primary vaccination from 6 weeks of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2023
CompletedStudy Start
First participant enrolled
January 15, 2024
CompletedFirst Posted
Study publicly available on registry
January 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2026
CompletedJanuary 19, 2024
January 1, 2024
2.3 years
December 19, 2023
January 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (45)
Anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in infants 6 weeks of age part of the dose-finding cohort
Anti-Salmonella Typhimurium (S. Typhimurium) O antigen (Ag) total IgG and anti-Salmonella Enteritidis (S. Enteritidis) OAg total IgG GMCs are assessed.
At Day 85 (28 days after the second study intervention administration)
Percentage of adult participants 18-50 years of age with solicited administration site events
The solicited administration site events are pain, redness and swelling.
During 7 days after the first study intervention administration occurring at Day 1
Percentage of adult participants 18-50 years of age with solicited administration site events
The solicited administration site events are pain, redness and swelling.
During 7 days after the second study intervention administration occurring at Day 57
Percentage of adult participants 18-50 years of age with solicited systemic events
The solicited systemic events are fever, headache, myalgia, arthralgia and fatigue. Fever is defined as axillary temperature higher than or equal to (\>=) 38.0 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F).
During 7 days after the first study intervention administration occurring at Day 1
Percentage of adult participants 18-50 years of age with solicited systemic events
The solicited systemic events are fever, headache, myalgia, arthralgia and fatigue. Fever is defined as axillary temperature \>= 38.0 °C/100.4 degrees °F.
During 7 days after the second study intervention administration occurring at Day 57
Percentage of adult participants 18-50 years of age with unsolicited adverse events (AEs)
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
During 28 days after the first study intervention administration occurring at Day 1
Percentage of adult participants 18-50 years of age with unsolicited adverse events (AEs)
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
During 28 days after the second study intervention administration occurring at Day 57
Percentage of adult participants 18-50 years of age with serious adverse events (SAEs)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in abnormal pregnancy outcomes.
From first study intervention administration (Day 1) up to the end of study participation (Day 85)
Percentage of adult participants 18-50 years of age with adverse events (AEs) leading to withdrawal from the study or discontinuation of study intervention
An AE is any untoward medical occurrence (an unfavorable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. Any AEs that lead to discontinuation of study intervention and/or the study are considered under this outcome measure.
From first study intervention administration (Day 1) up to the end of study participation (Day 85)
Percentage of adult participants 18-50 years of age with deviations from reference ranges l or baseline values for hematological, renal and hepatic panel test results
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
At Day 8 (7 days after the first study intervention administration)
Percentage of adult participants 18-50 years of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
At Day 64 (7 days after the second study intervention administration)
Percentage of child participants 24-59 months of age with solicited administration site events
The solicited administration site events are pain, redness and swelling.
During 7 days after the first study intervention administration occurring at Day 1
Percentage of child participants 24-59 months of age with solicited administration site events
The solicited administration site events are pain, redness and swelling.
During 7 days after the second study intervention administration occurring at Day 57
Percentage of child participants 24-59 months of age with solicited systemic events
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness and vomiting. Fever is defined as axillary temperature \>= 38.0 °C/100.4 degrees °F.
During 7 days after the first study intervention administration occurring at Day 1
Percentage of child participants 24-59 months of age with solicited systemic events
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness and vomiting. Fever is defined as axillary temperature \>= 38.0 °C/100.4 degrees °F.
During 7 days after the second study intervention administration occurring at Day 57
Percentage of child participants 24-59 months of age with unsolicited AEs
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
During 28 days after the first study intervention administration occurring at Day 1
Percentage of child participants 24-59 months of age with unsolicited AEs
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
During 28 days after the second study intervention administration occurring at Day 57
Percentage of child participants 24-59 months of age 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 or any other situation based on appropriate medical or scientific judgement.
From first study intervention administration (Day 1) up to the end of study participation (Day 85)
Percentage of child participants 24-59 months of age with AEs leading to withdrawal from the study or discontinuation of study intervention
An AE is any untoward medical occurrence (an unfavorable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. Any AEs that lead to discontinuation of study intervention and/or the study are considered under this outcome measure.
From first study intervention administration (Day 1) up to the end of study participation (Day 85)
Percentage of child participants 24-59 months of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
At Day 8 (7 days after the first study intervention administration)
Percentage of child participants 24-59 months of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
At Day 64 (7 days after the second study intervention administration)
Percentage of infant participants 9 months of age with solicited administration site events
The solicited administration site events are pain, redness and swelling.
During 7 days after the first study intervention administration occurring at Day 1
Percentage of infant participants 9 months of age with solicited administration site events
The solicited administration site events are pain, redness and swelling.
During 7 days after the second study intervention administration occurring at Day 85
Percentage of infant participants 9 months of age with solicited administration site events
The solicited administration site events are pain, redness and swelling.
During 7 days after the third study intervention administration occurring at Day 169
Percentage of infant participants 9 months of age with solicited systemic events
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting. Fever is defined as axillary temperature \>= 38.0 °C/100.4 degrees °F.
During 7 days after the first study intervention administration occurring at Day 1
Percentage of infant participants 9 months of age with solicited systemic events
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting. Fever is defined as axillary temperature \>= 38.0 °C/100.4 degrees °F.
During 7 days after the second study intervention administration occurring at Day 85
Percentage of infant participants 9 months of age with solicited systemic events
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting. Fever is defined as axillary temperature \>= 38.0 °C/100.4 degrees °F.
During 7 days after the third study intervention administration occurring at Day 169
Percentage of infant participants 9 months of age with unsolicited adverse events (AEs)
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
During 28 days after the first study intervention administration occurring at Day 1
Percentage of infant participants 9 months of age with unsolicited adverse events (AEs)
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
During 28 days after the second study intervention administration occurring at Day 85
Percentage of infant participants 9 months of age with unsolicited adverse events (AEs)
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
During 28 days after the third study intervention administration occurring at Day 169
Percentage of infant participants 9 months of age 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 or any other situation based on appropriate medical or scientific judgement.
From first study intervention administration (Day 1) up to the end of study participation (Day 337)
Percentage of infant participants 9 months of age with adverse events (AEs) leading to withdrawal from the study or discontinuation of study intervention
An AE is any untoward medical occurrence (an unfavorable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. Any AEs that lead to discontinuation of study intervention and/or the study are considered under this outcome measure.
From first study intervention administration (Day 1) up to the end of study participation (Day 337)
Percentage of infant participants 9 months of age with deviations from reference range or baseline values for hematological, renal and hepatic panel test results
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
At Day 8 (7 days after the first study intervention administration)
Percentage of infant participants 9 months of age with deviations from reference range or baseline values for hematological, renal and hepatic panel test results
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
At Day 92 (7 days after the second study intervention administration)
Percentage of infant participants 9 months of age with deviations from reference range or baseline values for hematological, renal and hepatic panel test results
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
At Day 176 (7 days after the third study intervention administration)
Percentage of infant participants 6 weeks of age with solicited administration site events
The solicited administration site events are pain, redness and swelling.
During 7 days after the first study intervention administration occurring at Day 1 in the Priming phase
Percentage of infant participants 6 weeks of age with solicited administration site events
The solicited administration site events are pain, redness and swelling.
During 7 days after the second study intervention administration occurring at Day 57 in the Priming phase
Percentage of infant participants 6 weeks of age with solicited systemic events
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting. Fever is defined as axillary temperature \>= 38.0 °C/100.4 degrees °F.
During 7 days after the first study intervention administration occurring at Day 1 in the Priming phase
Percentage of infant participants 6 weeks of age with solicited systemic events
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting. Fever is defined as axillary temperature \>= 38.0 °C/100.4 degrees °F.
During 7 days after the second study intervention administration occurring at Day 57 in the Priming phase
Percentage of infant participants 6 weeks of age with unsolicited adverse events (AEs)
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
During 28 days after the first study intervention administration occurring at Day 1 in the Priming phase
Percentage of infant participants 6 weeks of age with unsolicited adverse events (AEs)
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
During 28 days after the second study intervention administration occurring at Day 57 in the Priming phase
Percentage of infant participants 6 weeks of age with 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 or any other situation based on appropriate medical or scientific judgement.
From first study intervention administration (Day 1) up to 28 days after second study intervention (Day 85)
Percentage of infant participants 6 weeks of age with adverse events (AEs) leading to MR-VAC administration withdrawal from the study or discontinuation of study intervention
An AE is any untoward medical occurrence (an unfavorable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. Any AEs that lead to discontinuation of study intervention and/or the study are considered under this outcome measure.
From first study intervention administration (Day 1) up to 28 days after second study intervention (Day 85)
Percentage of infant participants 6 weeks of age with deviations from reference ranges or baseline values for hematological, renal, and hepatic panel test results
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
At Day 8 (7 days after the first study intervention administration) in the Priming phase
Percentage of infant participants 6 weeks of age with deviations from reference ranges or baseline values for hematological, renal, and hepatic panel test results at Day 64
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
At Day 64 (7 days after the second study intervention administration) in the Priming phase
Secondary Outcomes (23)
Percentage of infant participants 6 weeks of age with solicited administration site events
During 7 days after the third study intervention administration occurring at Day 232 in the Booster phase
Percentage of infant participants 6 weeks of age with solicited systemic events
During 7 days after the third study intervention administration occurring at Day 232 in the Booster phase
Number of infant participants 6 weeks of age with unsolicited AEs
During 28 days after the third study intervention administration occurring at Day 232 in the Booster phase
Percentage of infant participants 6 weeks of age with SAEs
From 28 days after the second study intervention administration (Day 85) up to end of study participation (Day 400)
Percentage of infant participants 6 weeks of age with adverse events (AEs) leading to withdrawal from the study or discontinuation of study intervention
From 28 days after the second study intervention administration (Day 85) up to end of study participation (Day 400)
- +18 more secondary outcomes
Study Arms (22)
Adults_Dose C Group
EXPERIMENTALAdults 18-50 years of age, part of the safety cohort, randomized to receive 2 doses of the iNTS-GMMA Dose C vaccine at Day 1 and Day 57.
Adults_Control Group
ACTIVE COMPARATORAdults 18-50 years of age, part of the safety cohort, randomized to receive 1 dose of the MenACWY vaccine at Day 1 and 1 dose of Placebo at Day 57.
Children_Dose B Group
EXPERIMENTALChildren 24-59 months of age, part of the safety cohort, randomized to receive 2 doses of the iNTS-GMMA Dose B vaccine at Day 1 and Day 57.
Children_Control B Group
ACTIVE COMPARATORChildren 24-59 months of age, part of the safety cohort, randomized to receive 2 doses of the MenACWY vaccine at Day 1 and Day 57.
Children_Dose C Group
EXPERIMENTALChildren 24-59 months of age, part of the safety cohort, randomized to receive 2 doses of the iNTS-GMMA Dose C vaccine at Day 1 and Day 57.
Children_Control C Group
ACTIVE COMPARATORChildren 24-59 months of age, part of the safety cohort, randomized to receive 2 doses of the MenACWY vaccine at Day 1 and Day 57.
Infants_9M_Dose A Group
EXPERIMENTALInfants 9 months of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose A vaccine at Day 1, Day 85 and Day 169. These infants also receive an Expanded Program on Immunization (EPI) vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
Infants_9M_Control A Group
ACTIVE COMPARATORInfants 9 months of age, part of the safety cohort, randomized to receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPaHBV-IPV+Hib vaccine at Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
Infants_9M_Dose B Group
EXPERIMENTALInfants 9 months of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose B vaccine at Day 1, Day 85 and Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
Infants_9M_Control B Group
ACTIVE COMPARATORInfants 9 months of age, part of the safety cohort, randomized to receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPaHBV-IPV+Hib vaccine at Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
Infants_9M_Dose C Group
EXPERIMENTALInfants 9 months of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose C vaccine at Day 1, Day 85 and Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
Infants_9M_Control C Group
ACTIVE COMPARATORInfants 9 months of age, part of the safety cohort, randomized to receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPaHBV-IPV+Hib vaccine at Day 169. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
Infants_6W_Dose A Group
EXPERIMENTALInfants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose A vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
Infants_6W_Control A Group
ACTIVE COMPARATORInfants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the MenACWY vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). To allow completion of the vaccination schedule a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
Infants_6W_Dose B Group
EXPERIMENTALInfants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose B vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
Infants_6W_Control B Group
ACTIVE COMPARATORInfants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the MenACWY vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). To allow completion of the vaccination schedule a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
Infants_6W_Dose C Group
EXPERIMENTALInfants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the iNTS-GMMA Dose C vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
Infants_6W_Control C Group
ACTIVE COMPARATORInfants 6 weeks of age, part of the safety cohort, randomized to receive 3 doses of the MenACWY vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). To allow completion of the vaccination schedule a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants also receive an EPI vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
Infants_6W_Dose A_2 Group
EXPERIMENTALInfants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the iNTS-GMMA Dose A vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last iNTS-GMMA administration at Day 232, and the pentavalent vaccine (DTPwHepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial.
Infants_6W_Dose B_2 Group
EXPERIMENTALInfants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the iNTS-GMMA Dose B vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last iNTS-GMMA administration at Day 232, and the pentavalent vaccine (DTPwHepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial.
Infants_6W_Dose C_2 Group
EXPERIMENTALInfants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the iNTS-GMMA Dose C vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last iNTS-GMMA administration at Day 232, and the pentavalent vaccine (DTPwHepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial.
Infants_6W_Control_2 Group
ACTIVE COMPARATORInfants 6 weeks of age, part of the dose-finding cohort, randomized to receive 3 doses of the MenACWY vaccine at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase). To allow completion of the vaccination schedule a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings. These infants also receive an EPI vaccination with the following vaccines: Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine administered concomitantly during the last study intervention administration at Day 232, and the pentavalent vaccine (DTPw-HepB-Hib), the Pneumococcal conjugate vaccine, and the inactivated polio vaccine administered at the same time, at 6, 10 and 14 weeks of age, at the local EPI vaccination centers, and not part of the current clinical trial.
Interventions
Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants\_9M\_Dose A, Infants\_9M\_Control A, Infants\_9M\_Dose B, Infants\_9M\_Control B, Infants\_9M\_Dose C and Infants\_9M\_Control C groups. - at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants\_6W\_Dose A, Infants\_6W\_Control A, Infants\_6W\_Dose B, Infants\_6W\_Control B, Infants\_6W\_Dose C and Infants\_6W\_Control C groups. - at Day 232, concomitantly during the last study intervention administration to infants in Infants\_6W\_Dose A\_2, Infants\_6W\_Dose B\_2, Infants\_6W\_Dose C\_2 and Infants\_6W\_Control\_2 groups.
Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants\_9M\_Dose A, Infants\_9M\_Control A, Infants\_9M\_Dose B, Infants\_9M\_Control B, Infants\_9M\_Dose C and Infants\_9M\_Control C groups. - at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants\_6W\_Dose A, Infants\_6W\_Control A, Infants\_6W\_Dose B, Infants\_6W\_Control B, Infants\_6W\_Dose C and Infants\_6W\_Control C groups. - at Day 232, concomitantly during the last study intervention administration to infants in Infants\_6W\_Dose A\_2, Infants\_6W\_Dose B\_2, Infants\_6W\_Dose C\_2 and Infants\_6W\_Control\_2 groups.
Pentavalent vaccine is administered, as part of an Expanded Program on Immunization (EPI) vaccination, at the local EPI vaccination centers, and not part of the current clinical trial, at 6, 10 and 14 weeks of age to infants in Infants\_6W\_Dose A\_2, Infants\_6W\_Dose B\_2, Infants\_6W\_Dose C\_2 and Infants\_6W\_Control\_2 groups.
Pneumococcal vaccine is administered, as part of an Expanded Program on Immunization (EPI) vaccination, at the local EPI vaccination centers, and not part of the current clinical trial, at 6, 10 and 14 weeks of age to infants in Infants\_6W\_Dose A\_2, Infants\_6W\_Dose B\_2, Infants\_6W\_Dose C\_2 and Infants\_6W\_Control\_2 groups.
Inactivated polio vaccine is administered, as part of an Expanded Program on Immunization (EPI) vaccination, at the local EPI vaccination centers, and not part of the current clinical trial, at 6, 10 and 14 weeks of age to infants in Infants\_6W\_Dose A\_2, Infants\_6W\_Dose B\_2, Infants\_6W\_Dose C\_2 and Infants\_6W\_Control\_2 groups.
-2 doses of iNTS-GMMA Dose C vaccine administered intramuscularly, at Day 1 and Day 57 to adults and children in the Adults\_Dose C and Children\_Dose C groups; -3 doses of iNTS-GMMA Dose C vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants\_9M\_Dose C group, and at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase) to infants in the Infants\_6W\_Dose C and Infants\_6W\_Dose C\_2 groups.
-2 doses of iNTS-GMMA Dose B vaccine administered intramuscularly, at Day 1 and Day 57 to children in the Children\_Dose B group; -3 doses of iNTS-GMMA Dose B vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants\_9M\_Dose B group, and at Day 1, Day 57 (during the Priming phase) and Day at 232 (during the Booster phase) to infants in the Infants\_6W\_Dose B and Infants\_6W\_Dose B\_2 groups.
3 doses of iNTS-GMMA Dose A vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants\_9M\_Dose A group, and at Day 1, Day 57 (during the Priming phase) and Day at 232 (during the Booster phase) to infants in the Infants\_6W\_Dose A and Infants\_6W\_Dose A\_2 groups.
-1 dose of MenACWY vaccine administered intramuscularly at Day 1 to adults in the Adults\_Control group; -2 doses of MenACWY vaccine administered intramuscularly at Day 1 and Day 57 to children in the Children\_Control B and Children\_Control C groups, and at Day 1 and Day 85 to infants in the Infants\_9M\_Control A, Infants\_9M\_Control B and Infants\_9M\_Control C groups; -3 doses of MenACWY vaccine administered intramuscularly at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase) to infants in the Infants\_6W\_Control A, Infants\_6W\_Control B, Infants\_6W\_Control C and Infants\_6W\_Control\_2 groups. A 4th dose of MenACWY vaccine is administered after the trial ends, to infants in the aforementioned study groups, as per the licensed indication and in private vaccination settings.
1 dose of DTPa-HBV-IPV+Hib vaccine administered intramuscularly at Day 169 to infants in the Infants\_9M\_Control A, Infants\_9M\_Control B and Infants\_9M\_Control C groups.
1 dose of Placebo administered intramuscularly at Day 57 to adults in the Adults\_Control group.
Eligibility Criteria
You may qualify if:
- All participants (adults, children, infants at 9 months of age and infants at 6 weeks of age) will be enrolled in the clinical site in Ghana and must satisfy ALL the following criteria at study entry:
- Participants and/or participants' parent(s)/Legally Acceptable Representative(s) (LAR), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
- Written or witnessed/thumb printed informed consent obtained from the participant/parent(s)/LAR(s) of the participant prior to performance of any study-specific procedure.
- Healthy participants as established by medical history, clinical examination, and laboratory investigations.
- Participants satisfying screening requirements.
- Participants negative for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C.
- Adult participants must satisfy ALL the following criteria at study entry:
- A male or female between and including 18 and 50 years of age at the time of the first study intervention administration.
- Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
- Female participants of childbearing potential may be enrolled in the study if the participant:
- has practiced adequate contraception for 1 month prior to study intervention administration, and:
- has a negative pregnancy test on the day of study intervention administration, and
- has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration series.
- The Ghana card will be used as source document to verify the ages for the adults.
- Child participants must satisfy ALL the following criteria at study entry:
- +8 more criteria
You may not qualify if:
- Medical conditions
- Known exposure to S. Typhimurium or S. Enteritidis during the period starting at birth for infants and children, and at 3 years for adults, as documented by patient records
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
- Hypersensitivity, including allergy, to medicinal products or medical equipment whose use is foreseen in this study.
- Progressive, unstable, or uncontrolled clinical conditions.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- Major congenital defects, as assessed by the investigator.
- Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Acute disease and/or fever at the time of enrollment (fever is defined as temperature ≥ 38.0°C).
- Recurrent history or uncontrolled neurological disorders or seizures.
- Any clinically significant hematological and/or biochemical laboratory abnormality.
- Undernutrition defined as WHO Z-score less than -2 SD.
- Malaria infection defined as the presence of asexual parasites in the blood.
- Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
- Any behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the study.
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
- European & Developing Countries Clinical Trials Partnershipcollaborator
- Kwame Nkrumah University of Science and Technologycollaborator
- Pedvac iNTS consortiumcollaborator
Study Sites (1)
GSK Investigational Site
Kumasi, Ghana
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2023
First Posted
January 19, 2024
Study Start
January 15, 2024
Primary Completion
April 27, 2026
Study Completion
April 27, 2026
Last Updated
January 19, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- 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.
- 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.
IPD for this study will be made available via the Clinical Study Data Request site.