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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 in children (24-59 months of age) and finally in infants (9 months and 6 weeks of age). Infants are the target for primary vaccination from 6 weeks of age.
The study will be conducted as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults_Dose C Group | Experimental | Adults, 18-50 years of age, will receive 2 doses of the iNTS-GMMA Dose C (high dose) vaccine at Day 1 and Day 57. |
|
| Adults_Control Group | Active Comparator | Adults, 18-50 years of age, will receive 1 dose of the MenACWY vaccine at Day 1 and 1 dose of Placebo at Day 57. |
|
| Children_Dose B Group | Experimental | Children, 24-59 months of age, will receive 2 doses of the iNTS-GMMA Dose B (medium dose) vaccine at Day 1 and Day 57. |
|
| Children_Control B Group | Active Comparator | Children, 24-59 months of age, will receive 2 doses of the MenACWY vaccine at Day 1 and Day 57. |
|
| Children_Dose C Group | Experimental | Children, 24-59 months of age, will receive 2 doses of the iNTS-GMMA Dose C (high dose) vaccine at Day 1 and Day 57. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iNTS-GMMA Dose C | Biological | -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 and at Day 232 to infants in the Infants_6W_Dose C group. |
| Measure | Description | Time Frame |
|---|---|---|
| Number 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 |
| Number 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 |
| Number 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 |
| Number 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 |
| Number 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number 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 third study intervention administration occurring at Day 232 |
| Number of infant participants 6 weeks of age with solicited systemic events |
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Inclusion criteria:
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:
Adult participants must satisfy ALL the following criteria in the 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:
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:
Infant participants must satisfy ALL the following criteria at study entry:
The Road to Health Chart will be used as source document to confirm the ages for the children and infants.
Exclusion criteria:
Medical conditions
Prior/Concomitant therapy
History of receiving any investigational iNTS or GMMA vaccines in the participant's life.
Use of any investigational or non-registered product other than the study interventions during the period beginning 30 days before the first dose of study interventions, or their planned use during the study period.
Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 14 days before each dose and ending 28 days after the last dose of study interventions administration, with the exception of flu vaccines and vaccines administered as part of a public health vaccination campaign.
A vaccine not foreseen by the study protocol administered during the period starting at 14 days before the first dose and ending 14 days after the last dose of study interventions administration for live vaccines or 7 days in case of inactivated vaccines*, with the exception of flu vaccines or COVID-19 vaccine which may be considered on a case-by-case basis.
Under such circumstances, a participant may be considered eligible for study enrollment and/or study intervention administration after the appropriate window for delay has passed and inclusion/exclusion criteria have been re-checked, and if the participant is confirmed to be eligible.
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 intervention (vaccine, drug and device).
Other exclusions
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Kumasi | Ghana |
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
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Data will be collected in an observer-blind manner.
| Children_Control C Group |
| Active Comparator |
Children, 24-59 months of age, will receive 2 doses of the MenACWY vaccine at Day 1 and Day 57. |
|
| Infants_9M_Dose A Group | Experimental | Infants, 9 months of age, will receive 3 doses of the iNTS-GMMA Dose A (low dose) vaccine at Day 1, Day 85 and Day 169. These infants will 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 Comparator | Infants, 9 months of age, will receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPa-HBV-IPV+Hib vaccine at Day 169. These infants will also receive an EPI vaccination with MR-VAC and 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 | Experimental | Infants, 9 months of age, will receive 3 doses of the iNTS-GMMA Dose B (medium dose) vaccine at Day 1, Day 85 and Day 169. These infants will also receive an EPI vaccination withMR-VAC and 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 Comparator | Infants, 9 months of age, will receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPa-HBV-IPV+Hib vaccine at Day 169. These infants will also receive an EPI vaccination with MR-VAC and 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 | Experimental | Infants, 9 months of age, will receive 3 doses of the iNTS-GMMA Dose C (high dose) vaccine at Day 1, Day 85 and Day 169. These infants will also receive an EPI vaccination with MR-VAC and 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 Comparator | Infants, 9 months of age, will receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPa-HBV-IPV+Hib vaccine at Day 169. These infants will also receive an EPI vaccination with MR-VAC and 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 | Experimental | Infants, 6 weeks of age, will receive 3 doses of the iNTS-GMMA Dose A (low dose) vaccine at Day 1, Day 57 and at Day 232. These infants will also receive an EPI vaccination with MR-VAC and 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 Comparator | Infants, 6 weeks of age, will receive 3 doses of the MenACWY vaccine at Day 1, Day 57 and at Day 232 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 will receive an EPI vaccination with MR-VAC and 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 | Experimental | Infants, 6 weeks of age, will receive 3 doses of the iNTS-GMMA Dose B (medium dose) vaccine at Day 1, Day 57 and at Day 232. These infants will also receive an EPI vaccination with MR-VAC and 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 Comparator | Infants ,6 weeks of age, will receive 3 doses of the MenACWY vaccine at Day 1, Day 57 and at Day 232. 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 will also receive an EPI vaccination with MR-VAC and 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 | Experimental | Infants ,6 weeks of age, will receive 3 doses of the iNTS-GMMA Dose C (high dose) vaccine at Day 1, Day 57 and at Day 232. These infants will also receive an EPI vaccination with MR-VAC and 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 Comparator | Infants ,6 weeks of age, will receive 3 doses of the MenACWY vaccine at Day 1, Day 57 and at Day 232. 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 will also receive an EPI vaccination with MR-VAC and 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. |
|
|
| iNTS-GMMA Dose B | Biological | -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 and Day at 232 to infants in the Infants_6W_Dose B group. |
|
| iNTS-GMMA Dose A | Biological | 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 and Day at 232 to infants in the Infants_6W_Dose A group. |
|
| MenACWY | Biological | -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 and at Day 232 to infants in the Infants_6W_Control A, Infants_6W_Control B and Infants_6W_Control C 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. |
|
|
| DTPa-HBV-IPV+Hib | Combination Product | 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. |
|
|
| Placebo | Drug | 1 dose of Placebo administered intramuscularly at Day 57 to adults in the Adults_Control group. |
|
| Measles and Rubella vaccine | Biological | 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. |
|
|
| Yellow Fever vaccine | Biological | 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. |
|
| Number 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 |
| Number 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) |
| Number 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) |
| Number 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 8 (7 days after the first study intervention administration) |
| Number 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) |
| Number 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 |
| Number 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 |
| Number 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 |
| Number 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 |
| Number of child participants 24-59 months of age with unsolicited AEs | During 28 days after the first study intervention administration occurring at Day 1 |
| Number of child participants 24-59 months of age with unsolicited AEs | During 28 days after the second study intervention administration occurring at Day 57 |
| Number of child participants 24-59 months of age with serious adverse events (SAEs) | From first study intervention administration (Day 1) up to the end of study participation (Day 85) |
| Number of child participants 24-59 months of age with AEs leading to withdrawal from the study or discontinuation of study intervention | From first study intervention administration (Day 1) up to the end of study participation (Day 85) |
| Number of child participants 24-59 months of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results | At Day 8 (7 days after the first study intervention administration) |
| Number of child participants 24-59 months of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results | At Day 64 (7 days after the second study intervention administration) |
| Number 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 |
| Number 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 |
| Number 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 |
| Number 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 |
| Number 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 |
| Number 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 |
| Number of infant participants 9 months of age with unsolicited adverse events (AEs) | During 28 days after the first study intervention administration occurring at Day 1 |
| Number of infant participants 9 months of age with unsolicited adverse events (AEs) | During 28 days after the second study intervention administration occurring at Day 85 |
| Number of infant participants 9 months of age with unsolicited adverse events (AEs) | During 28 days after the third study intervention administration occurring at Day 169 |
| Number of infant participants 9 months of age with serious adverse events (SAEs) | From first study intervention administration (Day 1) up to the end of study participation (Day 337) |
| Number of infant participants 9 months of age with adverse events (AEs) leading to withdrawal from the study or discontinuation of study intervention | From first study intervention administration (Day 1) up to the end of study participation (Day 337) |
| Number of infant participants 9 months of age with deviations from reference range or baseline values for hematological, renal and hepatic panel test results | At Day 8 (7 days after the first study intervention administration) |
| Number of infant participants 9 months of age with deviations from reference range or baseline values for hematological, renal and hepatic panel test results | At Day 92 (7 days after the second study intervention administration) |
| Number of infant participants 9 months of age with deviations from reference range or baseline values for hematological, renal and hepatic panel test results | At Day 176 (7 days after the third study intervention administration) |
| Number 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 |
| Number 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 |
| Number 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 |
| Number 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 |
| Number of infant participants 6 weeks of age with unsolicited adverse events (AEs) | During 28 days after the first study intervention administration occurring at Day 1 |
| Number of infant participants 6 weeks of age with unsolicited adverse events (AEs) | During 28 days after the second study intervention administration occurring at Day 57 |
| Number of infant participants 6 weeks of age with SAEs | From first study intervention administration (Day 1) up to 28 days after second study intervention (Day 85) |
| Number 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 | From first study intervention administration (Day 1) up to 28 days after second study intervention (Day 85) |
| Number 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 8 (7 days after the first study intervention administration) |
| Number 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 | At Day 64 (7 days after the second study intervention administration) |
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 232 |
| Number of infant participants 6 weeks of age with unsolicited AEs | During 28 days after the third study intervention administration occurring at Day 232 |
| Number 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) |
| Number of infant participants 6 weeks of age with adverse events (AEs) leading to withdrawal from the study or withholding further study intervention administration | From 28 days after the second study intervention administration (Day 85) up to end of study participation (Day 400) |
| Number 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 239 (7 days after the study intervention administration) |
| 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. | At Days 1 and 57 (before each study intervention administration) and at Days 29 and 85 (28 days after each study intervention administration) |
| 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) |
| 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) |
| 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. | At Days 1, 57 and 232 (before each study intervention administration) at Days 29, 85 and 260 (28 days after each study intervention administration) and at Day 239 (7 days after the third study intervention administration) |
| Number 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 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) |
| Number 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) |
| Number 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) |
| Number 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. | At Days 29, 85 and 260 (28 days after each study intervention administration) and at Day 239 (7 days after the third study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration) |
| ID | Term |
|---|---|
| D012480 | Salmonella Infections |
| ID | Term |
|---|---|
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C525703 | MenACWY |
| D022401 | Meningococcal Vaccines |
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
| D012411 | Rubella Vaccine |
| D022341 | Yellow Fever Vaccine |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D014765 | Viral Vaccines |
Not provided
Not provided