| OUTCOMES |
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Type of outcome
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Outcome
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Timepoint(s) at which outcome measured
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| Primary Outcome |
Outcome measure 1 - Anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in infants 6 weeks of age part of the dose-finding cohort. Anti-Salmonella Typhimurium (S. Typhimurium) O antigen (Ag) total IgG and anti-Salmonella Enteritidis (S. Enteritidis) OAg total IgG GMCs are assessed. |
At Day 260 - 28 days after the third study intervention administration |
| Primary Outcome |
Outcome measure 2 - Percentage of adult participants 18–50 years of age with solicited administration site events after the first study intervention administration. The solicited administration site events are pain, redness and swelling. |
During 7 days after the first study intervention administration occurring at Day 1 |
| Primary Outcome |
Outcome measure 3 - Percentage of adult participants 18–50 years of age with solicited administration site events after the second study intervention administration. The solicited administration site events are pain, redness and swelling.
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During 7 days after the second study intervention administration occurring at Day 57 |
| Primary Outcome |
Outcome measure 4 - Percentage of adult participants 18–50 years of age with solicited systemic events after the first study intervention administration. The solicited systemic events are fever, headache, myalgia, arthralgia and fatigue.
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During 7 days after the first study intervention administration occurring at Day 1 |
| Primary Outcome |
Outcome measure 5 - Percentage of adult participants 18–50 years of age with solicited systemic events after the second study intervention administration. The solicited systemic events are fever, headache, myalgia, arthralgia and fatigue. |
During 7 days after the second study intervention administration occurring at Day 57 |
| Primary Outcome |
Outcome measure 6 - Percentage of adult participants 18–50 years of age with unsolicited adverse events (AEs) after the first study intervention administration. An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
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During 28 days after the first study intervention administration occurring at Day 1 |
| Primary Outcome |
Outcome measure 7 - Percentage of adult participants 18–50 years of age with unsolicited adverse events (AEs) after the second study intervention administration. An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
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During 28 days after the second study intervention administration occurring at Day 57 |
| Primary Outcome |
Outcome measure 8 - 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.
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From first study intervention administration /Day 1/ up to the end of study participation /Day 85/ |
| Primary Outcome |
Outcome measure 9 - Percentage of adult participants 18–50 years of age with adverse events (AEs) leading to withdrawal from the study or withholding further study intervention administration. 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.
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From first study intervention administration /Day 1/ up to the end of study participation /Day 85/ |
| Primary Outcome |
Outcome measure 10 - Percentage of adult participants 18–50 years of age with deviations from normal or baseline values for hematological, renal and hepatic panel test results at Day 8
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.
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At Day 8 - 7 days after the first study intervention administration |
| Primary Outcome |
Outcome measure 11 - Percentage of adult participants 18–50 years of age with deviations from normal 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 |
| Primary Outcome |
Outcome measure 12 - Percentage of child participants 24–59 months of age with solicited administration site events after the first study intervention administration
The solicited administration site events are pain, redness and swelling.
|
During 7 days after the first study intervention administration occurring at Day 1 |
| Primary Outcome |
Outcome measure 13 - Percentage of child participants 24–59 months of age with solicited administration site events after the second study intervention administration
The solicited administration site events are pain, redness and swelling.
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During 7 days after the second study intervention administration occurring at Day 57 |
| Primary Outcome |
Outcome measure 14 - Percentage of child participants 24–59 months of age with solicited systemic events after the first study intervention administration
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness and vomiting.
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During 7 days after the first study intervention administration occurring at Day 1 |
| Primary Outcome |
Outcome measure 15 - Percentage of child participants 24–59 months of age with solicited systemic events after the second study intervention administration
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness and vomiting.
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During 7 days after the second study intervention administration occurring at Day 57 |
| Primary Outcome |
Outcome measure 16 - Percentage of child participants 24–59 months of age with unsolicited AEs after the first study intervention administration
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
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During 28 days after the first study intervention administration occurring at Day 1 |
| Primary Outcome |
Outcome measure 17 - Percentage of child participants 24–59 months of age with unsolicited AEs after the second study intervention administration
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any ‘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 |
| Primary Outcome |
Outcome measure 18 - 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.
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From first study intervention administration /Day 1/ up to the end of study participation /Day 85/ |
| Primary Outcome |
Outcome measure 19 - Percentage of child participants 24–59 months of age with AEs leading to withdrawal from the study or withholding further study intervention administration
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/ |
| Primary Outcome |
Outcome measure 20 - Percentage of child participants 24–59 months of age with deviations from normal or baseline values for hematological, renal and hepatic panel test results at Day 8
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.
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At Day 8 - 7 days after the first study intervention administration |
| Primary Outcome |
Outcome measure 21 - Percentage of child participants 24–59 months of age with deviations from normal 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.
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At Day 64 - 7 days after the second study intervention administration |
| Primary Outcome |
Outcome measure 22 - Percentage of infant participants 9 months of age with solicited administration site events after the first study intervention administration
The solicited administration site events are pain, redness and swelling.
|
During 7 days after the first study intervention administration occurring at Day 1 |
| Primary Outcome |
Outcome measure 23 - Percentage of infant participants 9 months of age with solicited administration site events after the second study intervention administration
The solicited administration site events are pain, redness and swelling.
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During 7 days after the second study intervention administration occurring at Day 85 |
| Primary Outcome |
Outcome measure 24 - Percentage of infant participants 9 months of age with solicited administration site events after the third study intervention administration
The solicited administration site events are pain, redness and swelling.
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During 7 days after the third study intervention administration occurring at Day 169 |
| Primary Outcome |
Outcome measure 25 - Percentage of infant participants 9 months of age with solicited systemic events after the first study intervention administration
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness and vomiting.
|
During 7 days after the first study intervention administration occurring at Day 1 |
| Primary Outcome |
Outcome measure 26 - Percentage of infant participants 9 months of age with solicited systemic events after the second study intervention administration
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness and vomiting.
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During 7 days after the second study intervention administration occurring at Day 85 |
| Primary Outcome |
Outcome measure 27 - Percentage of infant participants 9 months of age with solicited systemic events after the third study intervention administration
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness and vomiting.
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During 7 days after the third study intervention administration occurring at Day 169 |
| Primary Outcome |
Outcome measure 28 - Percentage of infant participants 9 months of age with unsolicited adverse events (AEs) after the first study intervention administration
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
|
During 28 days after the first study intervention administration occurring at Day 1 |
| Primary Outcome |
Outcome measure 29 - Percentage of infant participants 9 months of age with unsolicited adverse events (AEs) after the second study intervention administration
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any ‘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 |
| Primary Outcome |
Outcome measure 30 - Percentage of infant participants 9 months of age with unsolicited adverse events (AEs) after the third study intervention administration
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
|
During 28 days after the third study intervention administration occurring at Day 169 |
| Primary Outcome |
Outcome measure 31 - 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/ |
| Primary Outcome |
Outcome measure 32 - Percentage of infant participants 9 months of age with adverse events (AEs) leading to withdrawal from the study or withholding further study intervention administration
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/ |
| Primary Outcome |
Outcome measure 33 - Percentage of infant participants 9 months of age with deviations from normal or baseline values for hematological, renal and hepatic panel test results at Day 8
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.
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At Day 8 - 7 days after the first study intervention administration |
| Primary Outcome |
Outcome measure 34 - Percentage of infant participants 9 months of age with deviations from normal or baseline values for hematological, renal and hepatic panel test results at Day 92
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.
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At Day 92 - 7 days after the second study intervention administration |
| Primary Outcome |
Outcome measure 35 - Percentage of infant participants 9 months of age with deviations from normal or baseline values for hematological, renal and hepatic panel test results at Day 176
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.
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At Day 176 - 7 days after the third study intervention administration |
| Primary Outcome |
Outcome measure 36 - Percentage of infant participants 6 weeks of age with solicited administration site events after the first study intervention administration
The solicited administration site events are pain, redness and swelling.
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During 7 days after the first study intervention administration occurring at Day 1 |
| Primary Outcome |
Outcome measure 37 - Percentage of infant participants 6 weeks of age with solicited administration site events after the second study intervention administration
The solicited administration site events are pain, redness and swelling.
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During 7 days after the second study intervention administration occurring at Day 57 |
| Primary Outcome |
Outcome measure 38 - Percentage of infant participants 6 weeks of age with solicited administration site events after the third study intervention administration
The solicited administration site events are pain, redness and swelling.
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During 7 days after the third study intervention administration occurring at Day 232 |
| Primary Outcome |
Outcome measure 39 - Percentage of infant participants 6 weeks of age with solicited systemic events after the first study intervention administration
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness and vomiting.
|
During 7 days after the first study intervention administration occurring at Day 1 |
| Primary Outcome |
Outcome measure 40 - Percentage of infant participants 6 weeks of age with solicited systemic events after the second study intervention administration
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness and vomiting.
|
During 7 days after the second study intervention administration occurring at Day 57 |
| Primary Outcome |
Outcome measure 41 - Percentage of infant participants 6 weeks of age with solicited systemic events after the third study intervention administration
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness and vomiting.
|
During 7 days after the third study intervention administration occurring at Day 232 |
| Primary Outcome |
Outcome measure 42 - Percentage of infant participants 6 weeks of age with unsolicited adverse events (AEs) after the first study intervention administration
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
|
During 28 days after the first study intervention administration occurring at Day 1 |
| Primary Outcome |
Outcome measure 43 - Percentage of infant participants 6 weeks of age with unsolicited adverse events (AEs) after the second study intervention administration
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any ‘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 |
| Primary Outcome |
Outcome measure 44 - Percentage of infant participants 6 weeks of age with unsolicited adverse events (AEs) after the third study intervention administration
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
|
During 28 days after the third study intervention administration occurring at Day 232 |
| Primary Outcome |
Outcome measure 45 - 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 the end of study participation /Day 400/ |
| Primary Outcome |
Outcome measure 46 - Percentage of infant participants 6 weeks of age with adverse events (AEs) leading to withdrawal from the study or withholding further study intervention administration
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 400/ |
| Primary Outcome |
Outcome measure 47 - Percentage of infant participants 6 weeks of age with deviations from normal or baseline values for hematological, renal and hepatic panel test results at Day 8
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 |
| Primary Outcome |
Outcome measure 48 - Percentage of infant participants 6 weeks of age with deviations from normal 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.
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At Day 64 - 7 days after the second study intervention administration |
| Primary Outcome |
Outcome measure 49 - Percentage of infant participants 6 weeks of age with deviations from normal or baseline values for hematological, renal and hepatic panel test results at Day 239
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.
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At Day 239 - 7 days after the third study intervention administration |
| Secondary Outcome |
Outcome measure 50 - Anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in adult participants 18–50 years of age
Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG GMCs are assessed.
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At Days 1 and 57 /before each study intervention administration/ and at Days 29 and 85 /28 days after each study intervention administration/ |
| Secondary Outcome |
Outcome measure 51 - Anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in child participants 24–59 months of age
Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG GMCs are assessed.
|
At Days 1 and 57 /before each study intervention administration/ and at Days 29 and 85 /28 days after each study intervention administration/ |
| Secondary Outcome |
Outcome measure 52 - Anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in infant participants 9 months of age
Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG GMCs are assessed.
|
At Days 1. 85 and 169 /before each study intervention administration/ and at Days 29, 113 and 197 /28 days after each study intervention administration/ |
| Secondary Outcome |
Outcome measure 53 - Anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in infant participants 6 weeks of age
Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG GMCs are assessed.
|
Days 1, 57, 232 /before each study intervention administration/. Days 29, 85, 260 /28 days after each study intervention administration/. Day 239 /7 days after the third study interven. administration |
| Secondary Outcome |
Outcome measure 54 - Percentage of adult participants 18–50 years of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise in anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) antibody concentration
Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgGantibody concentrations are assessed.
|
At Days 29 and 85 /28 days after each study intervention administration/ compared to Day 1 /baseline, prior to first study intervention administration/ |
| Secondary Outcome |
Outcome measure 55 - Percentage of child participants 24–59 months of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise in anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) antibody concentration
Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG antibody concentrations are assessed.
|
At Days 29 and 85 /28 days after each study intervention administration/ compared to Day 1 /baseline, prior to first study intervention administration/ |
| Secondary Outcome |
Outcome measure 56 - Percentage of infant participants 9 months of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise in anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) antibody concentration
Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG antibody concentrations are assessed.
|
At Days 29, 113 and 197 /28 days after each study intervention administration/ compared to Day 1 /baseline, prior to first study intervention administration/ |
| Secondary Outcome |
Outcome measure 57 - Percentage of infant participants 6 weeks of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise in anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) antibody concentration
Anti-S. Typhimurium OAg total IgG and anti-S. Enteritidis OAg total IgG antibody concentrations are assessed.
|
Days 29, 85, 260 /28 days after each study intervention administration/. Day 239 /7 days after the third study intervention admin./ compared to Day 1 /baseline, prior to first study interv. admin./ |
| Secondary Outcome |
Outcome measure 58 - Anti-Hepatitis B surface (HBs) antigen (Ag) geometric mean concentrations (GMCs), in a subset of infant participants 6 weeks of age (dose-finding cohort)
|
At Day 1 /before the first study intervention administration/ and at Day 85 /28 days after the third pentavalent vaccine administration/ |
| Secondary Outcome |
Outcome measure 59 - Anti-Hib polyribosylribitol phosphate (PRP) geometric mean concentrations (GMCs), in a subset of infant participants 6 weeks of age (dose-finding cohort)
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At Day 1 /before the first study intervention administration/ and at Day 85 /28 days after the third pentavalent vaccine administration/ |
| Secondary Outcome |
Outcome measure 60 - Anti-measles immunoglobulin G (IgG) antibody geometric mean concentrations (GMCs), in a subset of infant participants 6 weeks of age (dose-finding cohort)
|
At Day 232 /before MR-VAC administration/ and at Day 260 /28 days after MR-VAC administration/ |
| Secondary Outcome |
Outcome measure 61 - Anti-rubella immunoglobulin G (IgG) antibody geometric mean concentrations (GMCs), in a subset of infant participants 6 weeks of age (dose-finding cohort)
|
At Day 232 /before MR-VAC administration/ and at Day 260 /28 days after MR-VAC administration/ |
| Secondary Outcome |
Outcome measure 62 - Percentage of a subset of infant participants 6 weeks of age (dose-finding cohort) achieving an anti-measles IgG antibody concentration of equal to or above (≥) 150 milli international units per milliliter (mIU/mL) and ≥ 200 mIU/mL
|
At Day 232 /before MR-VAC administration/ and at Day 260 /28 days after MR-VAC administration/ |
| Secondary Outcome |
Outcome measure 63 - Percentage of a subset of infant participants 6 weeks of age (dose finding cohort) achieving an anti-rubella IgG antibody concentration of ≥ 4 international units per milliliter (IU/mL) and ≥ 10 IU/mL
|
At Day 232 /before MR-VAC administration/ and at Day 260 /28 days after MR-VAC administration/ |
| Secondary Outcome |
Outcome measure 64 - Percentage of a subset of infant participants 6 weeks of age (dose finding cohort) achieving an anti-Hepatitis B IgG antibody concentration of ≥ 10 mIU/mL
|
At Day 1 /before the first study intervention administration/ and at Day 85 /28 days after third pentavalent vaccine administration/ |
| Secondary Outcome |
Outcome measure 65 - Percentage of a subset of infant participants 6 weeks of age (dose-finding cohort) achieving an anti-Hib polyribosylribitol phosphate (PRP) IgG antibody concentration of ≥ 0.15 microgram per milliliter (µg/mL)
|
At Day 1 /before the first study intervention administration/ and at Day 85 /28 days after third pentavalent vaccine administration/ |